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
Field trial of genetically modified maize tolerant to glyphosate

Proposed period of release:
01/04/2010 to 30/11/2014

Name of the Institute(s) or Company(ies)
Plant Production Research Center, Research Institute of Plant Production Piešťany, Slovak Republic on behalf of LIMAGRAIN CENTRAL EUROPE.;

3. Is the same GMPt release planned elsewhere in the Community?

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

If yes, notification number(s):

Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
maizepoaceaezeazea maysmaysvarious lines and hybrids

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
Introduction of a tolerance to the glyphosate herbicide in maize plants by expression of a bacterial EPSPS protein insensitive to the herbicide. This herbicide acts as an inhibitor of this enzyme in plants. The enzyme 5-enolpyruvyl-shikimate-3-phosphate synthetase (or EPSPS) is involved in the biosynthetic pathway of the aromatic aminoacids (tryptophan, tyrosine and phenylalanine).

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:
Ubiquitin promoter: Saccharum officinarum non coding regulatory sequence

transit peptide Zea mays mays coding sequence

epsps Arthtrobacter globiformis coding sequence

CaMV terminator Cauliflower mosaic virus non coding regulatory sequence

RB / LB: Agrobacterium tumefaciens non-coding sequence

6. Brief description of the method used for the genetic modification:
Agrobacterium tumefaciens 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:
Evaluate the agronomic behavior, under various soil and climate conditions, of different transformation events expressing a bacterial gene conferring to maize a tolerance to the herbicide glyphosate. These events have been backcrossed into different experimental hybrids.
Perform regulatory trials to get the information necessary to file an application for placing on the market a transformation event of maize tolerant to glyphosate.
Evaluate the weed management program.
Collection of samples (leaves, silage, grain) for biochemical analyses.

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

Remark - without prolongation of validity, the authorization was amended in this way:
the size of the sites was changed – the total surface of site per location will not exceed 15 000 m², including the borders.

3. Size of the site (m2):
A maximum of 5 locations will be sown every year. The maximum surface occupied by GM plants on each site is :
• max 3000 m2 Herbicide selectivity trial
• max 3000 m2 Herbicide efficiency trial
• max 3000 m2 Testing of events

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:
No observation or data were collected leading to suppose any potential environmental and human health adverse effects. Such observations were made during previous releases of the same transformation events in the USA during the years 2007-2009 and in Spain in 2009.
These plants are unlikely to pose any risk to environment and human health.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
The introduced trait has no potential effects to modify the plant persistency in the environment. There are no wild relatives of corn in Europe and out-crossing is not possible. In this experiment, there is no modification of the direct or indirect interactions between the modified plants and target or non-target organisms. There is no expected effect on human health and on animal health. Plants will not be used as food or feed. At the end of the experiment, plants will be destroyed by chopping and then the wastes will be buried by ploughing. Post-harvest monitoring of the field will be conducted during one year, during which possible volunteers will be destroyed before flowering.
There is no short-term possible effect on specific cultivation management and harvesting techniques.
Potential environmental impact considered minimal, given the conditions of the field trial (location, field isolation, minimal contacts with fauna and flora, absence of wild relatives of maize species in the release areas...).

Brief description of any measures taken for the management of risks:
Release sites are located in intensive agriculture areas, spatially isolated from commercial maize crops.
Double seeds bags, prepared in the laboratory will be opened only on the site; the surplus of seeds in the planter after sowing will be collected and destroyed. The experiment will be inspected frequently during the release period; any environmental effect will be reported. After the harvest, plants will be chopped on the field and incorporated into the soil. Ears and seeds eventually collected will be transported in sealed and labeled double bags according to the regulation in force. During the following year, no commercial culture of maize will be grown on the field. Possible volunteers will be monitored and destroyed during one year following the end of experiment.

Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
Not applicable. However, any unanticipated adverse effect (environment and human health) observed on the site will be reported without delay to the authorities.

Final report

European Commission administrative information

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