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Notification report


General information

Notification Number
B/ES/10/45-CON

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
17/03/2010

Title of the Project
Field evaluation of genetically modified soybean event TPGM5003-0001 for its selectivity to different herbicides.

Proposed period of release:
21/03/2010 to 21/03/2011

Name of the Institute(s) or Company(ies)
Bayer CropScience SAS, Plant Health Science & Technology
14-20 rue Pierre Baizet
69009 Lyon - France;


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

Has the same GMPt been notified elsewhere by the same notifier?
No

Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
soybeanfabaceaeglycineglycine max

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
Herbicide tolerant

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:
Genetic elements which confer the phenotype herbicide tolerance.
(Confidential Annex)


6. Brief description of the method used for the genetic modification:
The transgenic event has been generated by direct gene transfer using linearized plasmids.

7. If the recipient or parental plant is a forest tree species, describe ways and extent of dissemination and specific factors affecting dissemination:
Not relevant

Experimental Release

1. Purpose of the release:
The purpose of this study is to evaluate the selectivity to different herbicides of the Genetically Modified Organism under open field conditions. No crosses are planned.

2. Geographical location of the site:
Province of Tarragona
Municipio Cambrils: 1 location


3. Size of the site (m2):
The location will have a maximum surface of 1500 square meters, including GM and no GM soybean. In the location other transformation event described in other notifications will be present.

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:
- The genetic change appears stable.
- The new genetically modified soybean share the characteristics of soybean plants in agricultural production and of soybean seed in commerce.
- There is no cause for concern to non-target organisms presented by the new plant varieties.
- The potential for gene flow, the transfer of herbicide tolerance to conventional
or wild soybean relatives, is very low.
- The consequence of gene flow would not be detrimental to current agronomic
systems and can be managed by current agricultural practices.


Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
Genetically modified soybean has the same behavior as conventional soybean except for the characters encoded by the inserted genes.
Due to the measures taken in the trials and the lack of wild relatives of soybean in Europe, it can be considered that gene transfer is unlikely to happen, neither to other species nor to conventional soybean.


Brief description of any measures taken for the management of risks:
The trial will be conducted with an isolation distance of 200 m from any other soybean. The field trial site will be surrounded with at least 4 rows of nontransgenic
soybean (pollen trap) which will be destroyed after flowering.
All the plant material will be destroyed.
Each site will be visited on a regular basis during the trial period.


Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
The planned field trial is designed to evaluate the agronomic aspects (selectivity evaluation to herbicides).
The planned field trial is not designed to address the impact of the release on human health.


Final report
-

European Commission administrative information

Consent given by the Member State Competent Authority:
No
06/05/2010 00:00:00
Remarks:
Withdrawn by the notifier.