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Notification report

General information

Notification Number
B/SE/09/13039

Member State to which the notification was sent
Sweden

Date of acknowledgement from the Member State Competent Authority
29/12/2009

Title of the Project
Potato line AM04-1020 with an altered starch composition

Proposed period of release:
01/04/2010 to 31/12/2014

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?
Yes:
Germany; Finland; Netherlands; Czech Republic;

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

If yes, notification number(s):
B/DE/05/173; B/DE/06/183; B/DE/07/191; B/FI/09/1MB; B/NL/05/05; B/NL/07/06;

Genetically modified plant

Complete name of the recipient or parental plant(s)

Common Name	Family Name	Genus	Species	Subspecies	Cultivar/breeding line
potato	solanaceae	solanum	solanum tuberosum	tuberosum	P800

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
- inhibition of granulebound starch synthase (GBSS), which yields a higher fraction of amylopectin in the starch

- marker gene ahas (imidazolinone tolerance) as selection gene to identify transgenic cells in tissue culture

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:
T-DNA borders, pTiT37, for incorporation into plant chromosome.
ahas gene, Arabidopsis thaliana, imidazolinone tolerance in plant material.
Promoter and terminator from nopaline synthase gene, Agrobacterium tumefaciens, gene regulation.
Promoter of gbss gene, Solanum tuberosum, gene regulation. The inverted repeat fragment of the gbss gene leads to a reduction of the amylose fraction in the starch of the potato tuber resulting in a concomitant increase in the levels of amylopectine.

6. Brief description of the method used for the genetic modification:
Plasmid DNA was introduced into the potato lines by Agrobacterium-mediated gene transfer technology.

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:
- Investigate the agricultural and industrial value of the modified line.
- Produce potato tubers for laboratory analyses.
- Produce seed potatoes for future trials and cultivation.

2. Geographical location of the site:
Boden, Halmstad, Haparanda, Kristianstad, Lidköping, Lomma, Luleå, Piteå, Skara, Umeå, Vara och Övertorneå municipalities.

3. Size of the site (m2):
Max 50 ha in total/year

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 adverse effects on the environment or human health have been recorded for other potato lines with ahas gene in previous field trials in Sweden since 2002 or with increased amylopectin content since 1993. The line AM04-1020 has also been cultivated in field since 2004 without and adverse effects on the environment or the health have been observed.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
The genetically modified potato line shows a shift of the tuber starch composition to amylopectin. No difference regarding persistence in agricultural habitats or invasiveness in natural habitats compared to conventional potato varieties is expected. Nor is it expected that a selective advantage or disadvantage is conferred to the GM lines via the introduced traits. Due to the measures to be taken during the release (distance to or absence of cultivated and wild relatives) will the potential for gene transfer virtually be excluded. Interactions of the GM potato lines with non-target species and resulting effects will be comparable to those of conventional potato varieties. No toxic or allergenic effects are expected from elevated levels of amylopectin, nor from the ahas gene. Measures in place under current field trial practice will safeguard that all tuber and plant material is properly managed, harvested, stored, transported or disposed of to minimize contact to humans or animals. No effects are expected on biogeochemical processes. The GM potato lines will be cultivated under conventional agricultural practices.

Brief description of any measures taken for the management of risks:
- isolation distance: 10 m for trials and according to the seed production regulation for seed production
- careful harvest to avoid volunteers
- transportation in specific vehicles, closed containers or double sacks
- adjusted crop rotation: fallow field the following year or cultivation of crop that allows efficient control of volunteers, one year without volunteers,
- no potato crop except for AM04-1020 for the following two years, one year without volunteers
- destruction of any waste material

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

Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
23/04/2010 00:00:00
Remarks: