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Notification report


General information

Notification Number
B/FR/06/01/14-CON

Member State to which the notification was sent
France

Date of acknowledgement from the Member State Competent Authority
16/12/2005

Title of the Project
Field experiment of genetically modified tobacco with a reduced content of cembranes on leaf surface

Proposed period of release:
01/04/2006 to 31/10/2008

Name of the Institute(s) or Company(ies)
LIBROPHYT SAS, Centre de Cadarache, Bat. 185
13115 St-Paul-Lez-Durance
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
tobaccosolanaceaenicotiananicotiana tabacumtabacumBasma Drama

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
The GMPt contains a tobacco gene fragment in both sense and antisense orientation under the control of its own promoter in order to silence the corresponding endogenous gene. Presence of this transgene results in a reduced content in cembranes (diterpenes) on the tobacco leaf surface.
The plants contain also a resistance gene marker that is expressed in the whole plant.
Supplemental confidential information is given in appendix I


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:
The gene of interest and its regulatory elements originate from plant species. The gene of interest is a partial fragment of (a) gene(s) that is (are) already present in the non-modified tobacco genome
The marker gene is from bacterial origin but contains a functional intron. The presence of the intron prevents the marker gene to be expressed in procaryotic organisms. The protein is not pathogenic to humans nor deleterious to the environment.

Supplemental confidential information is given in appendix II


6. Brief description of the method used for the genetic modification:
The transgene was introduced in tobacco via the Agrobacterium mediated transformation. Regeneration and selection of modified plants is performed on medium containing the selective agent, hygromycin. The transgene insertion and copy number is confirmed by the isolation of flanking sequences and southern analysis.

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 field trial aims at testing the agronomic performance of the modified plants compared to control plants. In particular, (i) the level of terpene secretion at the leaf surface will be evaluated during the course of the trial and (ii) the plant growth characteristics under various agronomic parameters such as irrigation and plant density.

2. Geographical location of the site:
France (location to be defined)

3. Size of the site (m2):
4800 genetic modified plants and 1200 wild type plants of the same cultivars will be grown in an area of 2000 m2

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 release of the same GM-plant was carried out previously.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
Tobacco is not a wild plant in Europe. Tobacco plants cannot survive the winter in Europe and the germination of tobacco seeds for cultivation is done in warm glass houses before transplanting in the field. The acquired trait in the modified plant does not affect resistance to cold or the ability to germinate in the field. Also, the genetically modified plants have an altered leaf surface composition but no new compounds are present. The only detectable variation is the reduction in cembranes. Finally, the GM-plant is resistant to the antibiotic hygromycin. This trait does not confer any competitive advantage to the GM-plant under standard cultivation.
Consequently, there is no anticipated selective advantage of the GM-plant in a natural environment.


Brief description of any measures taken for the management of risks:
To limit potential cross fertilization with cultivated tobacco, the plants will be harvested before flowering. Moreover, the fields will be located at least 500 m from the nearest tobacco field.

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

Final report
-

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
19/05/2006 00:00:00
Remarks: