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Notification report


General information

Notification Number
B/ES/09/40

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
10/03/2009

Title of the Project
Application to perform complementary field trials with Syngenta’s MIR604 maize product in Spain (2009).

Proposed period of release:
01/04/2009 to 30/11/2009

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:
Czech Republic; Slovak Republic; Romania;

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

If yes, notification number(s):
B/ES/03/13; B/ES/08/34; B/FR/03/03/03; B/HU/07/05; B/RO/08/01;

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:
Event MIR604 maize (hereafter referred to as ‘MIR604 maize’) expresses a modified Cry3A (mCry3A) protein for control of certain coleopteran pests and a phosphomannose isomerase (MIR604 PMI) protein, which acts as a selectable marker enabling transformed plant cells to utilize mannose as a primary carbon source.

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:
Promoter sequences: Promoter sequences from Zea mays. Provides root-preferential expression in Zea mays.

Insect tolerance gene: encodes a modified cry3A gene from Bacillus thuringiensis subsp. kurstaki which confers tolerance to certain coleopteran species.

Selectable marker: E. coli pmi gene encoding the enzyme phosphomannose isomerase (PMI). Catalyzes the isomerization of manno se-6-phosphate to fructose-6-phosphate.

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 gene expression.


6. Brief description of the method used for the genetic modification:
Transformation of MIR604 maize was conducted using immature maize embryos derived from a proprietary Zea mays line, via Agrobacterium mediated transformation.

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 complementary information relating to the performance of this maize product under European conditions, to produce maize for composition and expression analysis and production of nursery for multiplication and observation. They will also allow the further assessment of the event in the environment.

2. Geographical location of the site:
See following question.

3. Size of the site (m2):
Aragón:
- Miralsot: 800 m2.

Castilla y León:
- Valderas: 500 m2.
- Fontecha (Valdevimbre): 500 m2.
- Villamarco (Santas Martas): 500 m2.
- Campazas (León): 500 m2.
- Guarrate (Zamora): 500 m2.
- Castronuño (Valladolid): 500 m2.
- Marzales (Valladolid): 500 m2.

Cataluña:
- Lleida-1: 500 m2.
- Lleida-2: 700 m2.
- Lleida-3: 450 m2.
- Bellpuig-1: 500 m2.
- Bellpuig-3: 500 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 of MIR604 maize do not differ from the recipient plant in mode or rate of reproduction, dissemination or survivability of the plant. The MIR604 maize can be grown commercially in the USA and Canada.

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 of the event in the environment.

Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
09/06/2009 00:00:00
Remarks:
There are several Autonomous Communities as competent authorities for give the consent of these field trials:

- Aragón: 09/06/2009.
- Cataluña: 09/06/2009.
- Castilla y León: 16/06/2009.