Notification report

General information

Notification Number

Member State to which the notification was sent

Date of acknowledgement from the Member State Competent Authority

Title of the Project
Application to perform field trials with Syngenta’s MIR604 maize in Slovakia (2011-2014).

Proposed period of release:
01/04/2011 to 31/12/2014

Name of the Institute(s) or Company(ies)
Plant production research centre, Research Institute of Plant Production;

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

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

If yes, notification number(s):
B/ES/03/13; B/ES/08/33; B/ES/09/40; B/FR/03/03/03; B/RO/08/01;

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:
Is applied to conduct small scale field trial releases with MIR604 maize for research purposes. MIR604 maize expresses two transgenic proteins, a modified Cry3A (mCry3A) protein for control of certain coleopteran pests and a phosphomannose isomerase (MIR604 PMI) protein as a selectable marker.

Genetic modification

3. Type of genetic modification:

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 MIR604 maize:
Promoter sequences is 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 mannose-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 immature maize embryos using Agrobacterium tumefaciens LBA4404 (Negrotto et al, 2000).

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 this stacked maize product under European conditions, to produce maize for comparative and expression analysis and to study potential effects on non-target organisms. They will also allow the further assessment of the event in the environment.

2. Geographical location of the site:
Locations in Borovce, Gabčíkovo, Šaľa, (Slovak Republic)

3. Size of the site (m2):
A maximum of 3 locations will be sown every year. The total surface per location will not exceed 60.000 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 EU 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. 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:
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 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:
01/04/2011 00:00:00