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Country's Decision or any other Communication
Record information and status
Record ID
103659
Status
Published
Date of creation
2012-06-19 12:50 UTC (german_bch@bvl.bund.de)
Date of last update
2017-05-31 13:03 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
6786-01-0170; Decision regarding the deliberate release (field trial) of genetically modified potatoes (Solanum tuberosum, cultivar Walli) transformed with pMFI9-1 issued by the German Competent Authority
Date of the decision
2006-09-08
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
LfL Freising
Institut für Pflanzenbau und Pflanenzüchtung
Bayerische Landesanstalt für Landwirtschaft
Vöttinger Strasse 38

Freising, Bayern
Germany, 85354
Phone:+ 49 8161 71-5800
Fax:+ 49 8161 71-5809
Email:Poststelle@LfL.bayern.de
Url:http://www.lfl.bayern.de/ipz/biotechnologie/33232/index.php
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 needs to distinctively describe the LMO and it needs to be noted that this potato and its offspring is unfit for consumption.
- Genetically modified plant material has to be kept separate from non modified material at any time, e.g. during storage, field preparation, field trial and harvest.
- An inspection of the release site on unexpected biological traits of the LMO and reciprocal effects between the LMO and other organisms has to be accomplished weekly during the experimental release and sufficient risk measures have to be performed.
- During and after the field trial monthly inspection of the surrounding area [20 m] of the release site for transgenic potato volunteers and their manual removal and disposal has to be accomplished.
- All transgenic potatoes that are not intended to be used for further cultivation or analysis as well as transgenic potatoes that are found when cleaning the working equipment have to be disposed by disruption of their germination capacity.
- After harvest and in the following spring the first 20 cm of the soil of the release site has to be loosen up and uncovered potatoes as well as potatoes that are found on the working equipment have to be collected and disposed by disruption of their germination capacity. The release site must not be ploughed.
- After completion of the field trial an inspection of the release site for transgenic potato volunteers, their removal and disposal has to be accomplished during the growing season every 4 weeks. 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. 
- A sign indicating "Versuchpflanzen, nicht zum Verzehr oder zur Verfütterung geeignet" (test plants, unfit for use as food and feed) has to be put up at the release site.
- If it is intended to extract the starch of the transgenic potatoes in a technical plant the Federal Office of Consumer Protection and Food Safety (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, BVL) and the supervisory authorites of the federal states of the field trial and of the technical plant need to be informed in writing. By a contract between the developer of the LMO and the operator of the technical plant it has to be assured that the extracted starch and remaining plant material are not used in food and feed. If the technical plant is located within another member state of the European Union the transboundary movement requires the approval of the BVL a priori.
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 with altered starch quality
LfL Freising altered carbohydrate composition: increased amylopectin content
Show detection method(s)
Risk assessment
6786-01-0170; Summary of the risk assessment of a deliberate release (field trial) of genetically modified potatoes (Solanum tuberosum, cultivar Walli) transformed with pMFI9-1 issued by the German Competent Authority
Potato with altered starch quality
LfL Freising

altered carbohydrate composition: increased amylopectin content
Additional Information
Additional Information
- type of decision: field trial
- LMO: markergen-free amylopectin potato (Solanum tuberosum, cultivar Walli) transformed with vector pMFI9-1
- legal basis: Directive 2001/18/EC, Gentechnikgesetz (German Gene Technology Act)
- scope: test of field performance of LMO
- authorization valid from April 2006 to October 2015
- 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: 3 ha with max. 5 potato plants/m²

   
   
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