Notification report

General information

Notification Number

This notification has been withdrawn by the notifier

Member State to which the notification was sent

Date of acknowledgement from the Member State Competent Authority

Title of the Project
Application for the release into the environment of potato line AV43-6-G7 with an altered starch composition according to the Genetically Modified Organisms Decree, 2013 - 2017

Proposed period of release:
01/01/2013 to 31/12/2019

Name of the Institute(s) or Company(ies)
BASF Plant Science GmbH, Carl-Bosch-Strasse 38, D-67056 Ludwigshaven GERMANY;

3. Is the same GMPt release planned elsewhere in the Community?
Germany; Sweden; Czech Republic;

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

If yes, notification number(s):
B/CZ/11/1; B/NL/01/11; B/NL/03/04; B/NL/04/04; B/NL/07/04; B/NL/07/05; B/SE/11/919;

Genetically modified plant

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

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

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:
- T-DNA borders, pTiT37, Agrobacterium tumefaciens, for incorporation into plant chromosome.
- M13mp19 fragment, Escherichia coli, part of Lac operon (lacI)
- Genomic GBSS fragment, Solanum tuberosum, functional as a promoter in plants
- GBSS cDNA fragment; 5’ 1.1 kb part, Solanum tuberosum, sense orientation in relation to the promoter sequence
- GBSS cDNA fragment; 3’ 1.3 kb part, Solanum tuberosum, antisense orientation in relation to the promoter sequence, functional as spacer element
- GBSS cDNA fragment; 5’ 1.1 kb part, Solanum tuberosum, antisense orientation in relation to the promoter sequence
- pTiT37 fragment, Agrobacterium tumefaciens, containing the nopaline synthase gene terminator (tNOS), functional as a polyadenylation sequence in plants
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-derived DNA was introduced into the potato line by Agrobacterium-mediated gene transfer technology using a binary vector system.

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 genetically modified potato line AV43-6-G7 with an altered starch composition will be grown for field trials (testing) and/or experimental seed production.

2. Geographical location of the site:
The experimental fields will be located in the municipalities of Steenbergen (province Noord-Brabant), Borger-Odoorn (province Drenthe), Lingewaard (province Gelderland) and Overbetuwe (province Gelderland)

3. Size of the site (m2):
The maximum area for the release will be 10.000 m2 per location.

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:
Releases of the same plant line have been conducted in the Netherlands, Czech Republic and Sweden. No adverse impacts on the environment or human health have been recorded in any of the trials.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
The intended effect of the genetic modification is to alter the starch composition leading to essentially amylose-free potato starch produced out of potato line AV43-6-G7. No antibiotic or herbicide marker genes are present in line AV43 6-G7.
An altered starch composition cannot be expected to pose any health hazard to animals or humans, as only the ratio between amylopectin and amylose has been altered. The gene sequences inserted to alter the starch composition are not expressed as protein products. Thus, neither toxic nor allergenic effects can be expected as a result of the genetic modification intended to alter the starch composition.
No phenotypic and agronomic differences were detected during previous field trials. Therefore it can be assumed that interactions of potato line AV43-6-G7 with the biotic environment will be identical to such interactions of conventional potato varieties.
No difference with respect to persistence in agriculturally utilized habitats or invasiveness into natural habitats as compared to conventional potato varieties is expected.
Through the measures that are taken during the release, the distance from other cultivated potatoes and the absence of crossable wild species, the possibility of any gene transfer can be virtually ruled out. Even in the very improbable event that pollen were to be transferred to a potato plant outside the trial, no consequences are to be expected, since agricultural potato propagation takes place via tubers and not via seeds.
No effects on biogeochemical processes are expected, other than those which apply also to conventional potatoes.

Brief description of any measures taken for the management of risks:
- a distance to other commercially grown potatoes of 10 m will be kept
- transportation in closed containment
- careful harvest to avoid volunteers
- destruction of waste material
- no potato crop for the following year to allow volunteer monitoring
- the year following the field trial emerging volunteers will be destroyed by mechanical or herbicide treatment

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:
Not known