| | english | español | français |
Go to record ID

  Home|Finding Information|Record details   Printer-friendly version

Country's Decision or any other Communication
Record information and status
Record ID
103569
Status
Published
Date of creation
2012-06-01 11:19 UTC (german_bch@bvl.bund.de)
Date of last update
2017-05-31 12:56 UTC (german_bch@bvl.bund.de)
Date of publication
2017-07-13 15:45 UTC (ursula.monnerjahn@bmel.bund.de)

This document is also available in the following languages:
General information
Country submitting the decision or communication
  • Germany
Competent National Authority(ies) responsible for the decision or communication
Federal Office of Consumer Protection and Food Safety
Mauerstrasse 39-42
Berlin
Germany, 10117
Phone:+49-(0)3018-445-6500
Fax:+49-(0)3018-445-6099
Email:german_bch@bvl.bund.de
Url:http://www.biosafety-bch.de (english language),BVL Homepage (English)
Title / Reference number of the decision or communication
6786-01-0160; Decision regarding the deliberate release (field trial) of genetically modified potatoes (Solanum tuberosum, variety Albatros) pCB301-Kan-MaSpI-100xELP, pCB301-Kan-MaSpII-100xELP and pCB301-Kan-SO1-100xELP issued by the German Competent Authority
Date of the decision
2005-05-10
Is the decision taken prior to entry into force of the Protocol?
No
Jurisdiction
  • Germany
Is this an amendment to a previous decision / communication?
No
Decision or communication details
Subject(s) of the decision
  • Decision on LMOs for intentional introduction into the environment (according Article 10 or domestic regulatory framework)
Was the decision triggered by a request for a transboundary movement of LMOs into the country?
No
Does the decision apply to transboundary movements of LMO(s) into the country?
No
Importer’s or Applicant’s contact details
Institut für Pflanzengenetik und Kulturpflanzenforschung
Corrensstrasse 3 
Gatersleben
Germany, 06466
Phone:+49 (0)39482 5-0
Fax:+49 (0) 39482 5139
Email:info@ipk-gatersleben.de
Url:IPK Gatersleben
Result of the decision
  • Approval of the import/use of the LMO(s) with conditions
Conditions
- Fertile plant material has to be transported and stored in closed and clearly labelled repositories at any time outside the release site and laboratory. The label need to distinctively describe the LMO and it needs to be noted that this potato is unfit for consumption. All remaining fertile plant material has to be destroyed by disruption of the germination capacity.
- The release site needs to be labelled with signs indicating "test plant, unfit for consumption".
- Inspection of the release site has to be accomplished weekly during the experimental release.
- During cultivation of transgenic potatoes, after appearance of the leaves, all potato lines have to be tested for the presence of the nptII gene by PCR-based methods. In the case of nptII detection the respective plants have to be removed from the release site and disposed.
- During the field trial the formation of fertile seeds has to be prohibiten by collecting blossoms and/or berries from the plants.
- If the release site is threatened by flooding sufficient risk measures have to be performed, e.g. through enclosing the release site with sandbags or through removal of the plants to prevent spreading of fertile plant material outside the release site by moving water.
- After completion of the field trial as well as in the following spring time, the first 20 cm of soil of the release site have to be loosening up; the release site must not be plough. Uncovered potatoes need to be collected manually and disposed by disruption of their germination capacity
- After completion of the field trial a monthly inspection of the release site for transgenic potato volunteers, their documentation and removal and disposal has to be accomplished during the growing season. The inspection period has to be extended for another year if potato volunteers were observed. The release site must not be cultivated with plants impairing the detection of transgenic volunteers. 
Reasons
To comply with requirements of Directive 2001/18/EC, Gentechnikgesetz (German Gene Technology Act): reduce possibility of GMO spread/establishment.
Does the decision involve field trials?
Yes
Does the decision involve commercial release?
No
LMO identification
Potato modified to synthesise fusion spider silk/ elastin protein
Production of medical or pharmaceutical compounds (human or animal) Resistance to antibiotics - Kanamycin Use in industrial applications
Potato modified for the production of spider silk protein
Production of medical or pharmaceutical compounds (human or animal) Resistance to antibiotics - Kanamycin Use in industrial applications
Show detection method(s)
Potato modified to synthesise fusion spider silk fragment/ elastin protein
Production of medical or pharmaceutical compounds (human or animal) Resistance to antibiotics - Kanamycin Use in industrial applications
Risk assessment
6786-01-0160; Summary of the risk assessment of a deliberate release (field trial) of genetically modified potatoes (Solanum tuberosum, variety Albatros) pCB301-Kan-MaSpI-100xELP, pCB301-Kan-MaSpII-100xELP and pCB301-Kan-SO1-100xELP issued by the German Competent Authority
Potato modified to synthesise fusion spider silk/ elastin protein
Production of medical or pharmaceutical compounds (human or animal)
Resistance to antibiotics - Kanamycin
Use in industrial applications
Potato modified for the production of spider silk protein
Production of medical or pharmaceutical compounds (human or animal)
Resistance to antibiotics - Kanamycin
Use in industrial applications
Potato modified to synthesise fusion spider silk fragment/ elastin protein
Production of medical or pharmaceutical compounds (human or animal)
Resistance to antibiotics - Kanamycin
Use in industrial applications
Additional Information
Additional Information
 type of decision: field trial
 LMO: Solanum tuberosum, variety Albatros pCB301-Kan-MaSpI-100xELP, pCB301-Kan-MaSpII-100xELP and pCB301-Kan-SO1-100xELP
 legal basis: Directive 2001/18/EC, Gentechnikgesetz (German Gene Technology Act)
 scope: test of field performance of LMO
 authorization valid within the vegetation period of 2005
 locations: One experimental field located in Germany; for details see German LMO/GMO location register ( http://apps2.bvl.bund.de/stareg_web/localeSwitch.do?language=en&page=/showflaechen.do?)
 size: 2000 m² with max. 2 plants per m²
- Related publications:
Fischer R, Schillberg S, Scheller J, Conrad U (2005) Molecular Farming Plant-Made Pharmaceuticals and Technical Proteins: Production of spider silk proteins in transgenic tobacco and potato, Wiley-VCH Verlag GmbH & Co. KGaA, p 171-181