Notification report

General information

Notification Number

Member State to which the notification was sent

Date of acknowledgement from the Member State Competent Authority

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

Proposed period of release:
01/01/2006 to 31/12/2010

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

3. Is the same GMPt release planned elsewhere in the Community?

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

Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
spring 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 increase the level of total oil in the seed. The neomycin phosphotransferase II gene or the acetohydroxy acid synthase gene (ahas) have been used as selectable marker genes to identify transgenic cells in tissue culture.

Genetic modification

3. Type of genetic modification:

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 are lipid metabolic enzyme 1, lipid metabolic enzyme 3 and a DNA binding protein, all from Arabidopsis thaliana. The genes are used in two combinations: lipid metabolic enzyme 3 combined with each of the other two.

These genes of interest are regulated by promoters of genes for seed storage proteins from Vicia faba: the usp–promoter or the legumin B4 promoter. Alternatively a promoter from a constitutively expressed gene from Pisum sativum is used.

The terminators used are:
- the terminators of the octopine synthase gene and nopaline synthase gene from Agrobacterium tumefaciens;
- the terminator of the small subunit of the ribulose-1,5-bisphosphate carboxylase gene from Pisum sativum;
- the terminator of the 35S gene from the Cauliflower mosaic virus;
- the terminator of the legumin B3 gene from Vicia faba.

As selectable marker genes have been used:
- the neomycin phosphotransferease II gene (nptII) flanked by the nopaline synthase promoter and terminator from Agrobacterium tumefaciens,
- the acetohydroxy acid synthase gene (ahas) flanked by the shortened triosephosphate transporter promoter (both from A. thaliana) and the terminator region of the nopaline synthase gene from A. 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, Svalöv, Klippan and Vara.

3. Size of the site (m2):
Total Area will not exceed 150000 m2 (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:
The genes of interest have previously, as single gene constructs, been grown in field releases in Sweden 2005 (B/SE/04/8095). No specific or general impact on the environment or human health could be documented.

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 500 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 Field Manager 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:
05/05/2006 00:00:00