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Country's Decision or any other Communication
Record information and status
Record ID
110682
Status
Published
Date of creation
2016-07-13 10:06 UTC (german_bch@bvl.bund.de)
Date of last update
2020-08-06 13:22 UTC (german_bch@bvl.bund.de)
Date of publication
2020-08-07 05:50 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
6786-01-0150 (adv. 42010.0150); Decision regarding the risk assessment of a deliberate release (field trial) of the genetically modified potato (Solanum tuberosum L.) B33-LegHg-3'OCS 13, B33-LegHg-3'OCS 45, B33-LegHg-3'OCS 54 and B33-LegHg-3'OCS 57, issued by the German Competent Authority
Date of the decision
2004-03-18
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
Max Planck Institute of Molecular Plant Physiology (MPIMP)
Max-Planck-Institut für Molekulare Pflanzenphysiologie
Am Mühlenberg 1
Potsdam
Germany, 14476
Phone:+49 331 567 - 80
Fax:+49 331 567 - 84 08
Email:contact@mpimp-golm.mpg.de
Url:Max-Planck-Institut für Molekulare Pflanzenphysiologie
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 keept separately from non transgenic plant material. The label needs to distinctively describe the LMO and it needs to be noted that this potato is unfit for consumption (food and feed). All remaining fertile plant material has to be destroyed by disruption of their germination capacity.
- Inspection of the release site on unexpected biological traits of the LMO and reciprocal effects between LMO and other organisms has to be accomplished regularly, at least once every four weeks, during the experimental release.
-   Monthly inspection of the surrounding area (10 m) of the release site for transgenic potato volunteers and their removal and disposal.
-  After harvest the first 15-20 cm of upper soil of the release site have to be loosen up. Potato tubers that emerge during that procedure have to be manually collected, removed, and destroyed by disruption of their germination capacity (steaming or autoclaving).
- After completion of the field trial monthly inspection of release site and surrounding areas (10 m) for transgenic potato volunteers, their documentation and removal and disposal has to be accomplished for one year, or longer if volunteers were observed. No plant species must be cultivated on the release site that impairs the detection of transgenic potato volunteers.
-     A distance of no less than 10 m to other release sites with potatos has to be kept.
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 for increased oxygen supply to tubers
Changes in physiology and/or production Changes in quality and/or metabolite content - Carbohydrates Resistance to antibiotics - Kanamycin
Risk assessment
6786-01-0150 (adv. 42010.0150); Summary of the risk assessment of a deliberate release (field trial) of the genetically modified potato (Solanum tuberosum L.) B33-LegHg-3‘OCS 13, B33-LegHg-3‘OCS 45, B33-LegHg-3‘OCS 54 and B33-LegHg-3‘OCS 57, issued by the German Competent Authority
Potato modified for increased oxygen supply to tubers
Changes in physiology and/or production
Changes in quality and/or metabolite content - Carbohydrates
Resistance to antibiotics - Kanamycin
Additional Information
Additional Information
-  type of decision: field trial
-  LMO: B33-LegHg-3'OCS 13, B33-LegHg-3'OCS 45, B33-LegHg-3'OCS 54 and B33-LegHg-3'OCS 57
-  legal basis: Directive 2001/18/EC, Gentechnikgesetz (German Gene Technology Act)
-  scope: test of field performance of LMO
-  authorization valid from 18 March 2004 to 31 December 2008
-  locations: 1 experimental field located in 1 village 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: 620 m²/site/year
-  max. 800 LMO/site