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Notification report


General information

Notification Number
B/ES/11/18

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
03/01/2011

Title of the Project
Notification for the deliberate release of genetically modified MON-ØØ6Ø3-6 maize varieties in view of registration.

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

Name of the Institute(s) or Company(ies)
PIONEER HI-BRED AGRO SERVICIOS SPAIN S.L., Avenida Reino Unido, s/n
Edificios ADYTEC – Euroficinas, 2nda planta
41012 Sevilla;


3. Is the same GMPt release planned elsewhere in the Community?
No

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

If yes, notification number(s):
B/ES/03/09-CON; B/ES/04/07; B/ES/05/03; B/ES/05/08; B/ES/06/17; B/ES/06/22; B/ES/07/10; B/ES/08/15; B/ES/09/23; B/ES/10/35;

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:
MON-ØØ6Ø3-6 maize (referred to as NK603 maize) has been genetically modified to tolerate application of glyphosate herbicide, which allows the farmers to use a broad-spectrum, non-selective, systemic herbicide for the weeding of the maize fields.

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:
NK603 maize has been genetically modified by the introduction of cp4epsps genes, from Agrobacterium sp. strain CP4, that confer tolerance to glyphosate herbicide, along with their 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 CaMV e35S promoter + Zmhsp70 + ctp2, the NOS 3’ terminator.


6. Brief description of the method used for the genetic modification:
The genetic modification was done by Monsanto Company using particle acceleration method. Subsequently, maize plants tested in the trials have been obtained by traditional breeding.

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 NK603 maize varieties in view of collecting regulatory data for registration on the National Catalogue of varieties.

2. Geographical location of the site:
The release is planned at the following locations in Spain in 2011:
- Andalucía: Dos Hermanas (Sevilla), Los Palacios-Villafranca (Sevilla), Marchena (Sevilla), Alcalá del Río (Sevilla).
- Aragón: Tauste (Zaragoza), Villafranca de Ebro (Zaragoza)-(3 sites), Ejea de los Caballeros (Zaragoza), Nuez de Ebro (Zaragoza).
- Castilla-La Mancha: La Gineta (Albacete), Alpera (Albacete)-(3 sites).
- Extremadura: Villanueva de la Serena (Badajoz), Villar de Rena (Badajoz).


3. Size of the site (m2):
Each site could have up to 1000 m² sown with the genetically modified NK603 maize subject of this notification.

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:
Field trials have already been conducted in several locations with this genetically modified maize and no environmental problems were reported for these trials. The transgenic plants have appeared normal in all respects. They behaved as the non-genetically modified maize plants, except for showing herbicide tolerance when glyphosate was applied, trait due to the genetic modification.
NK603 maize is no more regulated in the USA since 2000, in Canada and Japan since 2001, in South Africa since 2002, in Argentina since 2004, in the Philippines since 2005. It is widely cultivated and no adverse effects have been reported to our knowledge.


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 to the environment from the deliberate release of genetically modified maize tolerant to glyphosate are expected, as per information contained in Summary of the application EFSA-GMO-NL-2005-22.

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 other non-experimental maize crop. As it is done for any trial with conventional maize, the trial site will be surrounded by agronomic border rows of conventional maize of a similar maturity. The agronomic border rows will be also destroyed at the end of the release.
Grains are fixed on a cob and enclosed in many husks that protect the seeds from outside contact. Thus dispersal of individual kernels is not likely to occur. When seeds need to be collected for analysis; this will be done by sampling the whole ear and unused seeds will be destroyed.
If needed, the trial could be stopped by application of a herbicide other than glyphosate or by mechanical destruction, and incorporation into the soil by a deep ploughing.
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 by a deep ploughing. No plant or plant product coming from the trials will enter the food or feed chains.
After the release, the plot will be visited regularly during a one year-period in order to ensure removal of maize volunteers, if any. Although volunteer maize cannot generally survive hard winter, maize volunteers, if any, will be monitored in order to ensure their destruction prior to flowering.
No commercial maize crop will be planted on the same plot the following year.


Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
The purpose of the planned field trials is to collect specific data on the genetically modified maize varieties in the environment; the field trials are not designed to collect specific data linked with environmental impact studies. However, if any unanticipated adverse effects on the environment or human health were observed, they would be immediately reported to the competent Authority.

Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
15/03/2011 00:00:00
Remarks: