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Notification report


General information

Notification Number
B/CZ/05/642

Member State to which the notification was sent
Czech Republic

Date of acknowledgement from the Member State Competent Authority
02/03/2005

Title of the Project
Release into the environment of genetically modified potatoes with an altered starch composition

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

Name of the Institute(s) or Company(ies)
BASF (Czech) spol. s r.o., ;


3. Is the same GMPt release planned elsewhere in the Community?
No

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

If yes, notification number(s):
B/DE/03/153; B/DE/03/154; B/NL/03/09; B/NL/03/10; B/SE/95/28; B/SE/96/530; B/SE/97/1782; B/SE/99/1087;

Other notifications
22-1104/02 and 22-1019/02 (by Plant Science Sweden AB in Sweden), B/DE/03/154, B/DE/03/153, B/NL/03/10, B/NL/03/09 (BASF Plant Science GmbH), 22-4314/92, 22-4363/93, 22-28/95, 22-530/96, 22-1782/97, 22-2519/98, 22-1087/99, 22-1019/00 (by Amylogene HB and Plant Science Sweden AB).

Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
potatosolanaceaesolanumsolanum tuberosumtuberosum

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
A gene modifying the starch composition in potato tubers raising the level of amylopectin has been introduced into potato. An acetohydroxyacid synthase gene (lines AM02-1003, AM02-1005, AM02-1008, AM02-1010, AM02-1012, AM02-1014, AM02-1017) or a neomycin phophotransferase II gene (reference line EH92-527-1) have been used as selectable marker genes.

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 containing the coding region of potato gbss in antisense orientation relative to the promoter, flanked by the the gbss promoter from Solanum tuberosum and the polyadenylation sequence from Agrobacterium tumefaciens nopaline synthase gene has been inserted into potato lines AM02-1003, AM02-1005, AM02-1008, AM02-1010, AM02-1012, AM02-1014, AM02-1017 thus reducing the amount of amylose in the starch fraction. An ahas gene (acetohydroxyacid synthase) from Arabidopsis thaliana flanked by the nos gene promoter and the octopine synthase polyadenylation sequence from Agrobacterium tumefaciens serves as selectable marker gene conferring tolerance to Imazamox.

In potato event EH92-527-1 a gene consisting of a potato gbss (granule bound starch synthase) promoter, a fragment of the coding region of potato gbss in antisense orientation relative to the promoter and the polyadenylation sequence from Agrobacterium tumefaciens nopaline synthase gene (gene construct pHoxwG) have been inserted into potato thus reducing the amount of amylose in the starch fraction. In addition the neomycin phosphotransferase gene (nptII) connected to the Agrobacterium tumefaciens nopaline synthase promoter and polyadenylation signal has been inserted as selectable marker gene conferring resistance to kanamycin.


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. This is standard technology for potato transformation.

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 purpose of the release is, within the frame of safety studies to compile data on agronomical performance and environmental effects, as well as to collect plant material for further analyses, as well as to generate seed tubers.

2. Geographical location of the site:
Humpolec (Vysocina region)

3. Size of the site (m2):
Approx. 10 000 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 adverse impacts on the environment or human health have been recorded for the potato lines in previous field trials in Sweden, Germany and the Netherlands.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
The genetically modified potato lines show 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 acetohydroxyacid synthase or neomycin phosphotransferase II. Measures in place under current field trial practice will protect the trial from damage by animals as well as safeguard that all seed and plant material is properly managed, harvested, stored, transported or disposed of to minimize or prevent 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:
An isolation distance of 5 rows to other potato varieties will be observed. Planting and harvesting equipment will be cleaned on site to prevent the dispersal of GM tubers. There will be no potato cultivation on the release area the year following the release. Potential volunteers will be monitored and removed according to conventional agricultural practice. During the release the trial site will be monitored 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
16/06/2005 00:00:00
Remarks: