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Country's Decision or any other Communication
Record information and status
Record ID
111811
Status
Published
Date of creation
2017-03-03 09:23 UTC (german_bch@bvl.bund.de)
Date of last update
2017-04-18 12:57 UTC (german_bch@bvl.bund.de)
Date of publication
2017-07-13 11:48 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
6786-01-0100 (adv. 42010-0100); Decision regarding the risk assessment of a deliberate release (field trial) of genetically modified grape vine (Vitis vinifera), different independent lines, issued by the German Competent Authority
Date of the decision
1999-07-15
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 the laboratory. The label needs to distinctively describe the LMO. During the transport of the grapes the loss of grapes and seeds has to be prevented.
Tools that were in contact with the grape vines have to be cleaned thoroughly after use. Unintended spreading of the genetically modified plant material needs to be minimized.
A sign indicating " Versuchspflanzen, nicht zum Verzehr geeignet." (fild trial, plants not fit for consumption) has to be put up at the release site.
At the latest when the genetically modified grape vines start flowering, they have to be surrounded by three rows of non-modified, simultaneously flowering grape vines as shelter crops.
The gentically modified plants have to be disposed of properly. Remaining fertile plant material may be transferred into a laboratory if the germination capacity is disrupted in the course of the analyses.
After the completion of the trial, the genetically modified vines and the vines used as shelter crops have to be removed and destroyed, unless the approval for the trial will be extended. The shelter crops have to be destroyed in the same way as the genetically modified plants.
The Monitoring period after the end of the trial is one year.
The genetically modified grapes may only be consumed in the framework of this study. The people consuming the grapes must previously be informed about their genetic modification.
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
Grape vine modified for resistance to fungal pathogens
BAZ Resistance to antibiotics - Kanamycin Resistance to diseases and pests - Fungi
Grape vine modified for resistance to fungal pathogens
BAZ Resistance to antibiotics - Kanamycin Resistance to diseases and pests - Fungi
Grape vine modified for the expression of a marker gene
BAZ Resistance to antibiotics - Kanamycin Selectable marker genes and reporter genes
Risk assessment
6786-01-0100 (adv. 42010-0100) Summary of the risk assessment of a deliberate release (field trial) of genetically modified grape vine (Vitis vinifera) different independent lines, issued by the German Competent Authority
Grape vine modified for resistance to fungal pathogens
BAZ

Resistance to antibiotics - Kanamycin
Resistance to diseases and pests - Fungi
Grape vine modified for resistance to fungal pathogens
BAZ

Resistance to antibiotics - Kanamycin
Resistance to diseases and pests - Fungi
Grape vine modified for the expression of a marker gene
BAZ

Resistance to antibiotics - Kanamycin
Selectable marker genes and reporter genes
Additional Information
Additional Information
-  type of decision: field trial
-  LMO: different independent lines
-  legal basis: Directive 90/220/EEC, Gentechnikgesetz (German Gene Technology Act)
-  scope: test of field performance of LMO
-  authorization valid from 15 July 1999 to 31 December 2009
-  locations: 2 experimental fields located in 2 villages in Germany.
-  size:1,2 ha adv. 1,3 ha/site/year;
-  max. 10.000 LMO in total

-  There is no Summary Notification Information Format available on the Internet (WebSNIF) for B/DE/98/100

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.