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Country's Decision or any other Communication
Record information and status
Record ID
110743
Status
Published
Date of creation
2016-07-26 10:58 UTC (german_bch@bvl.bund.de)
Date of last update
2020-09-28 13:24 UTC (german_bch@bvl.bund.de)
Date of publication
2020-09-29 06:22 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
6786-01-0075 (adv. 42010.0075); Decision regarding the risk assessment of a deliberate release (field trial) of genetically modified sugarbeet (Beta vulgaris L) transformation events T 210-3 und T 219-5, issued by the German Competent Authority
Date of the decision
1998-03-05
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
PLANTA
PLANTA Angewandte Pflanzengenetik und Biotechnologie GmbH
Grimsehlstraße 31
Einbeck
Germany, 37574
Phone:+49 5561-3110
Fax:+49 5561-311243
Email:info@kws.de
Url:http://www.kws.de
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.
-  The release site has to be surrounded by shelter-crops.
-  Plant material that remains on the release site after the harvest has to be removed and destroyed by chopping or chemical treatment.
-  After completion of the field trial the release site and a surrounding area of 3 m have to be inspected for transgenic sugarbeet volunteers
-  No plant species must be cultivated on the release site that impairs the detection of transgenic sugarbeet 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
Sugarbeet modified for resistance to the Beet Necrotic Yellow Vein Virus
PLANTA Resistance to antibiotics - Kanamycin Resistance to diseases and pests - Viruses - Beet necrotic yellow virus (BNYV) Selectable marker genes and reporter genes
Sugarbeet modified for resistance to the Beet Necrotic Yellow Vein Virus
PLANTA Resistance to antibiotics - Kanamycin Resistance to diseases and pests - Viruses - Beet necrotic yellow virus (BNYV)
Risk assessment
6786-01-0075 (adv. 42010.0075); Summary of the risk assessment of a deliberate release (field trial) of the genetically modified sugarbeet (Beta vulgaris L.) transformation events T 210-3 and T 219-5, issued by the German Competent Authority
Sugarbeet modified for resistance to the Beet Necrotic Yellow Vein Virus
PLANTA

Resistance to antibiotics - Kanamycin
Resistance to diseases and pests - Viruses - Beet necrotic yellow virus (BNYV)
Selectable marker genes and reporter genes
Sugarbeet modified for resistance to the Beet Necrotic Yellow Vein Virus
PLANTA

Resistance to antibiotics - Kanamycin
Resistance to diseases and pests - Viruses - Beet necrotic yellow virus (BNYV)
Additional Information
Additional Information
-  type of decision: field trial
-  LMO: 2 transformants: T 210-3 and T 219-5.
-  legal basis: Directive 90/220/EEC, Gentechnikgesetz (German Gene Technology Act)
-  scope: test of field performance of LMO
-  authorization valid from 05 March 1998 to 31 December 2003
-  locations: 3 experimental field located in 3 villages 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: 25000 m²/site/year
-  max. 110000 LMO/site

-  There is no Summary Notification Information Format available on the Internet (WebSNIF) for B/DE/97/75