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 release into environment of genetically modified potatoes with altered starch metabolism (2010)

Proposed period of release:
01/04/2010 to 31/10/2010

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?
Finland; Sweden; Czech Republic;

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

If yes, notification number(s):
B/CZ/05/642; B/CZ/06/05; B/DE/03/153; B/DE/06/186; B/NL/03/09; B/SE/04/7942;

Other notifications
Other notifications: Dnr 22-4314/92, Dnr 22-4363/93, Dnr 22-28/95, Dnr 22 530/96, Dnr 22 1782/97, Dnr 22-2519/98, Dnr 22 1087/99, Dnr 22 1019/00 (all Sweden)

Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
potatosolanaceaesolanumsolanum tuberosumtuberosumPrevalent, Event EH92-527-1

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
- increased accumulation of amylopectin starch in tubers
- nptII gene (conferring tolerance to kanamycin) as selectable marker gene 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:
- T-DNA borders, pTiT37, for incorporation into the plant chromosome
- nptII (neomycin phosphotransferase) gene from E. coli, for kanamycin tolerance in plant material
- Promoter and terminator from nos (nopaline synthase) gene from A. tumefaciens, for gene regulation
- Promoter of the gbss (granule bound starch synthase) gene from S. tuberosum, for gene regulation
- Fragment of gbss (granule bound starch synthase) gene from S. tuberosum, coding region fragment in antisense

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. 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 the production of amylopectin potatoes for use as seed potatoes in the following years for cultivation and starch production under Part C if a respective approval is issued.

2. Geographical location of the site:
The release site will be located in Mecklenburg-Vorpommern.

3. Size of the site (m2):
39.54 ha (395,400 m2). The actually planted area will not exceed 20 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:
There have been previous releases of potato lines transformed with the same construct in Germany, Sweden, The Netherlands, and Czech Republic. 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 genetically modified potato line shows a shift of the tuber starch composition to amylopectin. A difference regarding persistence in agricultural habitats or invasiveness in natural habitats compared to conventional potato varieties is neither expected nor observed in any of the previous field trials. Conventional bred varieties with similar amylopectin/amylose ratio have never been reported to show any selective advantage. Likewise it is not expected or has been observed in previous field trials that a selective advantage or disadvantage is conferred to the GM line via the introduced traits.
No toxic or allergenic effects of the genetically modified potato are expected or have been observed in the studies for application for commercialization under Directive 2001/18/EC respective Regulation (EC) No 1829/2003.
Due to the measures to be taken during the release (distance to or absence of commercial potatoes) the potential for gene transfer will be virtually excluded. There are no wild plant species that are sexually compatible with potato in the EU.
The interactions of the genetically modified potato line with non-target organisms and the effects resulting from this will be comparable to those with conventional potato varieties. No significant differences have been observed in the application studies for commercialization under Directive 2001/18/EC regarding abundance and occurrence of non-target organisms. No effects on biogeochemical processes are expected, other than those that apply also to conventional potatoes. The GM potato line will be cultivated under conventional agricultural practices.

Brief description of any measures taken for the management of risks:
An isolation distance of 10 m 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 controlled according to conventional agricultural practice. During the release the trial site will be monitored at defined intervals.
Measures in place under current field trial practice will safeguard that all seed and plant material is properly managed, harvested, stored, transported or disposed of.

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:
09/03/2010 00:00:00
The application has been withdrawn by the notifier because the consent for cultivation of the genetically modified potato EH92-527-1 ("Amflora") has been given according to Part C of Directive 2001/18/EC.