General informationNotification NumberB/RO/10/04Member State to which the notification was sentRomaniaDate of acknowledgement from the Member State Competent Authority22/02/2010Title of the ProjectField trial of genetically modified maize tolerant to glyphosate.Proposed period of release:01/04/2010 to 30/12/2014Name of the Institute(s) or Company(ies)Limagrain Central Europe SE, Franta Sucursala Otopeni
Soseaua Bucuresti Ploiesti , km 15,2 , Otopeni , County Ilfov.
Tel. +40 21 312 3223 ; Fax +40 21 310 04334;
3. Is the same GMPt release planned elsewhere in the Community?Yes: Spain; Czech Republic; Has the same GMPt been notified elsewhere by the same notifier?NoGenetically modified plantComplete name of the recipient or parental plant(s)
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 amino-acids (tryptophan, tyrosine and phenylalanine).Genetic modification3. 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:Ubiquitin promoter: Saccharum officinarum (non coding regulatory sequence)
|Common Name||Family Name||Genus||Species||Subspecies||Cultivar/breeding line|
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.Experimental Release1. 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:• Dalga - county Calarasi
• Satu-Mare - county Satu Mare
• Caracal – county Olt3. Size of the site (m2):• Dalga - county Calarasi -4000 sq.m
• Satu-Mare - county Satu Mare-4000 sq.m
• Caracal – county Olt–4000 sq.m4. 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 nor data were collected indicating any potential environmental and human health adverse effects. 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 the environment and human health.Environmental Impact and Risk ManagementSummary 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 change 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 the following 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.
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 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 reportEuropean Commission administrative informationConsent given by the Member State Competent Authority:Yes14/06/2010 00:00:00Remarks: