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
Testing of NK603xMON810 (MON-ØØ6Ø3-6xMON-ØØ81Ø-6) maize. Request of the revision of the consent for deliberate releasing into environment for testing of genetically modified plant of maize (Zea mays) - NK603xMON810, nr 10 din 26 April 2006 – by the Romanian Ministry of Environment and Water Management.

Proposed period of release:
15/04/2007 to 01/12/2009

Name of the Institute(s) or Company(ies)
Pioneer Hi-Bred Seeds Agro SRL, Departamentul de cercetare
DN 2, km. 19,7
OP Afumaţi
Cod 077010
Jud. Ilfov

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

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

Genetically modified plant

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

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
The genetically modified NK603xMON810 maize varieties that will be tested in these field trials can tolerate the use of glyphosate herbicide for the weeding of maize field and are resistant to certain Lepidopteran insect pests such as the European corn borer (Ostrinia nubilalis). This maize was derived through traditional breeding methods between progeny of the genetically modified NK603 maize (from Monsanto), which is tolerant to glyphosate herbicide, and MON810 maize (from Monsanto), which is resistant to certain lepidopteran insects.

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:
The genes introduced in NK603xMON810 maize are the cp4epsps gene from Agrobacterium sp. strain CP4 that confers tolerance to glyphosate herbicide, like in NK603 maize, and the cry1Ab gene from Bacillus thuringiensis subsp. kurstaki that confers resistance to certain Lepidopteran insects such as Ostrinia nubilalis, like in MON810 maize, along with the regulatory components necessary for expression in maize plant:
- the cp4epsps gene, the P-ract1/ract1 intron + ctp2, the NOS 3’ terminator.
- the cp4epsps gene, the e35S promoter + Zmhsp70 + ctp2, the NOS 3’ terminator.
- the cry1Ab gene, the e35S promoter + Zmhsp70.

6. Brief description of the method used for the genetic modification:
No genetic modification was applied to obtain the NK603xMON810 maize varieties directly: they were derived through traditional breeding methods between progeny of the genetically modified NK603 maize and MON810 maize.
NK603 maize and MON810 maize were genetically modified by Monsanto using the particle acceleration method.

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 Release

1. Purpose of the release:
The purpose of the release is the testing of genetically modified NK603xMON810 maize varieties in view of registration on the National Catalogue of varieties of Romania.

2. Geographical location of the site:
Delibetrate release into the environment is planned for 2007 in the following locations:
•The official network of State Institute for Variety Testing and Registaration (ISTIS) where NK603xMON810 hybrids will be tested for collecting the necessary data for registration:
CTS Tecuci, Galaţi county, Lat.= 45.80993, Long.=27.40142
CTS Mircea Vodă, Brăila county, Lat.=45.10785, Long.=24.40990
CTS Dâlga, Călăraşi county, Lat.=44.42489, Long.=27.03711
CTS Râmnicu Sărat, Buzău county, Lat.=45.39225, Long.=27.06995
CTS Troianu, Teleorman county, Lat.=44.00437, Long.=25.02520

3. Size of the site (m2):
In 2006, each site could have up to 100 m²/hybrid sown with the genetically modified maize subject of this notification (NK603xMON810 maize), the total trial surface (all varieties and borders included) being larger.
In the following years, there could have up to 100 m²/hybrid of genetically modified NK603xMON810 maize sown per site, the total trial surface at each site (all varieties and borders included) being larger.

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:
Many field trials have already been conducted at several locations and no environmental problems were reported for these trials. The transgenic plants behaved as conventional maize. They were indistinguishable from the non-genetically modified maize plants except for showing tolerance to glyphosate herbicide and resistance to certain Lepidopteran insects such as the European Corn Borer, traits due to the genetic modifications.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
No risks to human and animal health or the environment from the deliberate release of genetically modified maize tolerant to glyphosate herbicide and resistant to certain Lepidopteran insects are expected, as per information contained in the Summary Notification Information Format of notification C/ES/04/01.

Brief description of any measures taken for the management of risks:
In order to limit any pollen flow from the genetically modified plants, a 200m-isolation distance will be maintained to any non-experimental maize crop. In addition, the trial site will be surrounded by four border rows of conventional maize of a similar relative maturity that will be also destroyed at the end of the release.
Seed dispersal of individual kernels does not generally occur. They are fixed on a cob and enclosed in many husks that protect the seeds from outside contact. When seeds need to be collected for analysis; this will be done by sampling the whole ear and unused seeds will be destroyed. In case of any emergency, the trial could be stopped by application of a non-selective herbicide other than glyphosate or by mechanical destruction, and incorporation into the soil.
At the end of the release all remaining plant matter that has not been harvested for analyses will be destroyed by chopping and incorporating into the soil. No plant or plant product coming from the trials will enter the food or feed chains.

Volunteer maize will be monitored during the following year. An herbicide treatment (other than glyphosate) will be used in order to ensure destruction if needed.
No commercial maize will be cultivated in the trial site the following year.

Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
Not applicable to this release.

Final report

European Commission administrative information

Consent given by the Member State Competent Authority:
23/04/2007 00:00:00
It also includes the import permit no. 13/23.04.2007