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Country's Decision or any other Communication
Record information and status
Record ID
111656
Status
Published
Date of creation
2017-02-02 12:18 UTC (german_bch@bvl.bund.de)
Date of last update
2020-11-23 12:18 UTC (german_bch@bvl.bund.de)
Date of publication
2020-11-24 12:21 UTC (nina.opitz@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
6786-01-0059 (adv. 42010.0059); Decision regarding the risk assessment of a deliberate release (field trial) of genetically modified potato (Solanum tuberosum L.), Ka1 to Ka4 and DHL 59/1 to DHL 59/20, issued by the German Competent Authority
Date of the decision
1997-04-29
Is the decision taken prior to entry into force of the Protocol?
Yes
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
BAZ
Institut für landwirtschaftliche Kulturen
Bundesanstalt für Züchtungsforschung an Kulturpflanzen (BAZ)
Erwin-Baur-Str. 27
Quedlinburg
Germany, 06484
Phone:+49 (0)3946 47 701
Fax:+49 (0)3946 47 255
Email:zl@jki.bund.de
Url:Julius-Kühn-Institut
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 and has to be kept separately from non transgenic plant material.
-  All remaining fertile plant material has to be destroyed by disruption of their germination capacity.
-  After harvest and in the following year, the first 15 - 20 cm of upper soil of the release site have to be loosened up. Potato tubers that emerge during that procedure have to be manually collected, removed, and destroyed by disruption of their germination capacity.
-  The release site must be inspected for transgenic volunteer potatoes at least once every four weeks. The inspection period has to be extended for another year if potato volunteers were observed.
-  After the end of the field trial no plant species must be cultivated on the release site that impairs the detection of transgenic potato volunteers.
Reasons
To comply with requirements of Directive 90/220/EEC, 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 for Potato Virus Y resistance
BAZ Resistance to antibiotics - Kanamycin Resistance to diseases and pests - Viruses - Potato virus Y (PVY) Selectable marker genes and reporter genes
Risk assessment
6786-01-0059 (adv. 42010.0059); Summary of the risk assessment of a deliberate release (field trial) of genetically modified potato (Solanum tuberosum L.) Ka1 to Ka4 and DHL 59/1 to DHL 59/20, issued by the German Competent Authority
Potato modified for Potato Virus Y resistance
BAZ

Resistance to antibiotics - Kanamycin
Resistance to diseases and pests - Viruses - Potato virus Y (PVY)
Selectable marker genes and reporter genes
Additional Information
Additional Information
-  type of decision: field trial
-  LMO: Ka1 to Ka4 and DHL 59/1 to DHL 59/20
-  legal basis: Directive 90/220/EEC, Gentechnikgesetz (German Gene Technology Act)
-  scope: test of field performance of LMO
-  authorization valid from 29 April 1997 to 31 December 2005
-  locations: 2 experimental field sites located in 2 villages in Germany, for details refer to the German LMO/GMO location register ( https://apps2.bvl.bund.de/stareg_web/localeSwitch.do?language=en&page=/showflaechen.do?)
-  size: 2.2 ha/site/year; 2.6 ha/site/year
-  max. 10000 LMO/site

-  There is no Summary Notification Information Format available on the Internet (WebSNIF) for B/DE/97/59

The decision on this deliberate release was made by the Robert Koch Institute (RKI).
The RKI was the competent national authority for the German Gene Technology Act before the competences were transferred to the Federal Office of Consumer Protection and Food Safety (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, BVL) on April 1st 2004. Deliberate releases that were authorized by the RKI prior to this date are now handled by the BVL.

   
   
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