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Notification report


General information

Notification Number
B/SE/04/8254

Member State to which the notification was sent
Sweden

Date of acknowledgement from the Member State Competent Authority
30/11/2004

Title of the Project
Application for the deliberate release of linseed lines genetically modified for altered oil composition in seed (2005-2009).

Proposed period of release:
01/04/2005 to 31/10/2009

Name of the Institute(s) or Company(ies)
Plant Science Sweden AB, Herman Ehles väg 2-4
SE-268 31 Svalöv
Sweden;


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
flaxlinaceaelinumlinum usitatissimumFlanders

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
Genes involved in fatty acid biosynthesis have been introduced into linseed in order to alter the fatty acid composition towards very long-chain polyunsaturated fatty acids. The neomycin phosphotransferase II gene is used as selectable marker gene.

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:
-A gene encoding a D6-Elongase from Physcomitrella patens connected to the usp (unknown seed protein) promoter from Vicia faba and the ocs (octopin synthase) terminator from Agrobacterium tumefaciens;

-a gene encoding a D6-desaturase from Phaeodactylum tricornutum connected to the usp (unknown seed protein) promoter from Vicia faba and the ocs (octopin synthase) terminator from Agrobacterium tumefaciens;

-a gene encoding a D5-desaturase from Phaeodactylum tricornutum connected to the usp (unknown seed protein) promoter from Vicia faba and the ocs (octopin synthase) terminator from Agrobacterium tumefaciens.

-The selectable marker gene neomycin phosphotransferase II flanked by the nos promoter and the ATG7 polyadenylation region from Agrobacterium tumefaciens.


6. Brief description of the method used for the genetic modification:
A standard Agrobacterium tumefaciens based transformation system was used for transformation of linseed.

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:
Evaluation of trait performance under field conditions and selection of lines for further testing and analysis of the trait.

2. Geographical location of the site:
Municipalities of Eslöv, Kristianstad, Svalöv, Klippan and Vara.

3. Size of the site (m2):
Total Area will not exceed 15 ha.

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 previous releases have been carried out.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
The genetically modified linseed lines show an altered fatty acid composition in seeds towards very long-chain polyunsaturated fatty acids. No difference regarding persistence in agricultural habitats or invasiveness in natural habitats compared to conventional linseed is expected. Nor is it expected that a selective advantage or disadvantage is conferred to the GM lines via the introduced trait. Due to the measures to be taken during the release (distance to or absence of cultivated and wild relatives) and linseed as a self-pollinating crop is the potential for permanent gene transfer will be virtually excluded. Interactions of the GM linseed lines with non-target species and resulting effects will be comparable to those of conventional linseed varieties. The potential of altered fatty acid composition in seed resulting in any effects on animal health from contact or consumption is considered negligible. Measures in place under current field trials in relation to handling, harvest, storing, transport or disposition will further minimize the probability of any negative effects on health or environment. No effects are expected on biogeochemical processes from the predicted trait. The GM linseed lines will be cultivated under conventional agricultural practices.

Brief description of any measures taken for the management of risks:
The distance from the nearest cultivation of linseed will be at least 400 m. Sowing- and harvesting machinery will be cleaned on site to prevent the dispersal of GM seed. Harvested seed material will be transported from the site in closed and labeled containers to the laboratories for analyses. Remaining seed will be inactivated. Vegetative plant material will be chopped and worked into the soil. The area will be controlled for volunteers. During the vegetation period and the monitoring period, the project leader and trained personnel will observe the trial site.

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
24/03/2005 00:00:00
Remarks: