Back

Notification report


General information

Notification Number
B/SE/04/8095

Member State to which the notification was sent
Sweden

Date of acknowledgement from the Member State Competent Authority
19/11/2004

Title of the Project
Application for the deliberate release of oilseed rape lines genetically modified for altered oil content in seed.

Proposed period of release:
01/04/2005 to 31/12/2009

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
oilseed rapebrassicaceaebrassicabrassica napusnapus (syn. oleifera)Westar

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
Genes involved in regulating the accumulation of seed storage compounds have been introduced into spring oilseed rape in order to alter the level of total oil in the seed. 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:
The genes of interest contain the usp (unknown seed protein) or legumin B4 promoter both from Vicia faba or a promoter from a constitutively expressed gene from Pisum sativum and the ocs (octopin synthase) terminator from Agrobacterium tumefaciens. The genes of interest are lipid metabolic enzyme 1 from Arabidopsis thaliana, ubiquinol-cytochrome C chaperone family protein from Arabidopsis thaliana, lipid metabolic enzyme 2 from Saccharomyces cerevisiae, primary carbon metabolism enzyme from Saccharomyces cerevisiae, protein kinase from Physcomitrella patens, myb-like DNA-binding protein from Physcomitrella patens, lipid metabolic enzyme 3 from Arabidopsis thaliana and a DNA binding protein from Arabidopsis thaliana. In all cases is the selectable marker gene neomycin phosphotransferease II flanked by the nos (nopaline synthase) promoter and the polyadenylation region of the nos gene 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 spring oilseed rape cv. Westar according to Molony et al. (1989) and Hoekema (1983).

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 15 000 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 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 oilseed rape lines show a modified level of the inherent seed component oil. No difference regarding persistence in agricultural habitats or invasiveness in natural habitats compared to conventional spring oilseed rape 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) the potential for permanent gene transfer will be virtually excluded. Interactions of the GM oilseed rape lines with non-target species and resulting effects will be comparable to those of conventional oilseed rape varieties. The potential of elevated levels of the seed component oil 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 oilseed rape 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 oilseed rape plants will be at least 400 m. A 6m-wide protective border containing unmodified male-sterile rape will surround experimental areas. 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 for a period of 4 consecutive years. During the release period the project leader and trained personnel will monitor the trial site at defined intervals.

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
04/05/2005 00:00:00
Remarks:
The notification consisted of nine gene constructs. Seven of these were given consent. Two were not given consent because too little information was given about these genes.