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Country's Decision or any other Communication
Record information and status
Record ID
111115
Status
Published
Date of creation
2016-10-26 12:57 UTC (german_bch@bvl.bund.de)
Date of last update
2020-11-05 12:44 UTC (german_bch@bvl.bund.de)
Date of publication
2020-11-06 08:32 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
6786-01-0124 (adv. 42010.0124); Decision regarding the risk assessment of a deliberate release (field trial) of genetically modified potato (Solanum tuberosum L.), 10 independent lines (35S-alphaTS, 35S-alphaPGMI, 35S-alphaPGMI-II), issued by the German Competent Authority
Date of the decision
2001-04-24
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 to 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 and/or 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 keep separately from non transgenic plant material.
-  The field site needs to be labeled, stating that this potato is unfit for consumption.
-  All remaining fertile plant material has to be destroyed by disruption of their germination capacity.
-  All machines that have been used on the release site have to be thoroughly cleaned on the release site.
-  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.
-  Following the deliberate release, the release site must be inspected for transgenic volunteer potatos at least once every four weeks. The inspection period has to be extended for another year if potato volunteers were observed. 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 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 methionine content in leaves and tubers
Changes in quality and/or metabolite content - Protein and amino acids Resistance to antibiotics - Kanamycin
Potato modified for altered starch content
Changes in quality and/or metabolite content - Carbohydrates Resistance to antibiotics - Kanamycin
Potato modified for altered starch content
Changes in quality and/or metabolite content - Carbohydrates Resistance to antibiotics - Kanamycin
Risk assessment
6786-01-0124 (adv. 42010.0124); Summary of the risk assessment of a deliberate release (field trial) of genetically modified potato (Solanum tuberosum L.), 10 independent lines (35S-alphaTS, 35S-alphaPGMI, 35S-alphaPGMI-II), issued by the German Competent Authority
Potato modified for increased methionine content in leaves and tubers
Changes in quality and/or metabolite content - Protein and amino acids
Resistance to antibiotics - Kanamycin
Potato modified for altered starch content
Changes in quality and/or metabolite content - Carbohydrates
Resistance to antibiotics - Kanamycin
Potato modified for altered starch content
Changes in quality and/or metabolite content - Carbohydrates
Resistance to antibiotics - Kanamycin
Additional Information
Additional Information
-  type of decision: field trial
-  LMO: 10 independent lines (35S-alphaTS, 35S-alphaPGMI, 35S-alphaPGMI-II
-  legal basis: Directive 2001/18/EC, Gentechnikgesetz (German Gene Technology Act)
-  scope: test of field performance of LMO
-  authorization valid from 24 April 2001 to 31 December 2003
-  locations: 1 experimental field located in 1 village 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: 7.7 ha/site/year
-  max. 2000 LMO/site/year

-  There is no Summary Notification Information Format available on the Internet (WebSNIF) for B/DE/01/124

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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