Germany | BCH-DEC-DE-111115 | Country's Decision or any other Communication | Biosafety Clearing-House

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Country's Decision or any other Communication (DEC)

published: 26 Oct 2016 last updated: 05 Nov 2020
Amendment
No
General information
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
EN
24 Apr 2001
Yes
Subject of the decision, notification, communication or declaration
  • Decision on LMOs for intentional introduction into the environment (according to Article 10 or domestic regulatory framework)
LMOs for intentional introduction into the environment
No
No
  • - Organization: Max Planck Institute of Molecular Plant Physiology (MPIMP) | BCH-CON-DE-49374-2
    Organization
    Max Planck Institute of Molecular Plant Physiology (MPIMP)
    , Max-Planck-Institut für Molekulare Pflanzenphysiologie
    Am Mühlenberg 1
    Potsdam,
    14476 , Germany
    Phone: +49 331 567 - 80 ,
    Fax: +49 331 567 - 84 08,
Yes
No
No
Result of the decision
Approval of the import and/or use of the LMO(s) with 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.
EN
To comply with requirements of Directive 2001/18/EC, Gentechnikgesetz (German Gene Technology Act): reduce possibility of GMO spread/establishment.
EN
LMO identification & risk assessment
  • BCH-LMO-SCBD-111086-1 Living Modified Organism 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
  • BCH-LMO-SCBD-111089-1 Living Modified Organism Potato modified for altered starch content
    Changes in quality and/or metabolite content - Carbohydrates Resistance to antibiotics - Kanamycin
  • BCH-LMO-SCBD-111090-1 Living Modified Organism Potato modified for altered starch content
    Changes in quality and/or metabolite content - Carbohydrates Resistance to antibiotics - Kanamycin
  • BCH-RA-DE-111114-3 Risk Assessment generated by a regulatory process 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 | Resistance to antibiotics, Changes in quality and/or metabolite content | Potato modified for altered starch content | Resistance to antibiotics, Changes in quality and/or metabolite content | Potato modified for altered starch content | Resistance to antibiotics, Changes in quality and/or metabolite content
Document on the decision, communication, notification or declaration
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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Record type Field Record(s)