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Country's Decision or any other Communication (DEC)
  |  
BCH-DEC-DE-111651-4   |   PDF   |   Print   |  
published: 07 Feb 2017 last updated: 15 Mar 2024
Amendment
No
General Information
6786-01-0103 (adv. 42010.0103); Decision regarding the risk assessment of a deliberate release (field trial) of genetically modified potato (Solanum tuberosum L.), 35S-alphaUMPS 21, 26, 29 and 73; B33-alphaUMPS 5, 8, 73 and 76; 35S-alphaAdK 4, 8, 20,24 and 28; 35S-StPT2 26, 27 and 45; 35S-PL 24, 28, 48 and 52; 35S-SAT 26 and 48, issued by the German Competent Authority
EN
11 May 1999
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
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 be kept separately from non transgenic plant material. The label needs to distinctively describe the identity of the LMO.
- All machines that have been used on the release site have to be thoroughly cleaned on the release site.
- All remaining fertile plant material has to be destroyed by disruption of its germination capacity.
-  The field site has to be surrounded by a fence with a label stating that these potatoes are unfit for consumption.
-  After harvest and in the following year, the first 15 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. The release site must not be ploughed after harvest of the potato tubers.
-  The release site must be inspected for transgenic volunteer potatoes at least once every four weeks. Potato tubers that emerge during that procedure have to be collected, removed, and destroyed by disruption of their germination capacity. If more than five genetically modified potatoes emerge per 150 m2 inspection of the release site has to be extended for one year. During the inspection period no plants must be cultivated that impair the detection of transgenic potato volunteers. 
EN
To comply with requirements of Directive 90/220/EEC, Gentechnikgesetz (German Gene Technology Act): reduce possibility of GMO spread/establishment.
EN
LMO identification & risk assessment
  • BCH-LMO-SCBD-111616-2 Living Modified Organism Potato modified for increased tuber weight
    Max Planck Institute of Molecular Plant Physiology(MPIMP) | Changes in physiology and/or production (Yield), Resistance to antibiotics (Kanamycin)
  • BCH-LMO-SCBD-111615-2 Living Modified Organism Potato modified for increased tuber weight
    Max Planck Institute of Molecular Plant Physiology(MPIMP) | Changes in physiology and/or production (Yield), Resistance to antibiotics (Kanamycin)
  • BCH-LMO-SCBD-111617-2 Living Modified Organism Potato modified for increased specific density
    Max Planck Institute of Molecular Plant Physiology(MPIMP) | Changes in physiology and/or production (Yield), Resistance to antibiotics (Kanamycin)
  • BCH-LMO-SCBD-111623-2 Living Modified Organism Potato modified for an enhanced phosphate content in leaves, roots and tubers
    Max Planck Institute of Molecular Plant Physiology(MPIMP) | Changes in physiology and/or production, Resistance to antibiotics (Kanamycin)
  • BCH-LMO-SCBD-111624-2 Living Modified Organism Potato modified for reduced cell wall stability
    Max Planck Institute of Molecular Plant Physiology(MPIMP) | Changes in quality and/or metabolite content, Resistance to antibiotics (Hygromycin)
  • BCH-LMO-SCBD-111622-2 Living Modified Organism Potato modified for tolerance to oxidative stress and heavy metals
    Max Planck Institute of Molecular Plant Physiology(MPIMP) | Resistance to antibiotics (Hygromycin), Tolerance to abiotic stress
  • BCH-RA-DE-111650-3 Risk Assessment generated by a regulatory process 6786-01-0103 (adv. 42010.0103); Summary of the risk assessment of a deliberate release (field trial) of genetically modified potato (Solanum tuberosum L.) 35S-alphaUMPS 21, 26, 29 and 73; B33-alphaUMPS 5, 8, 73 and 76; 35S-alphaAdK 4, 8, 20,24 and 28; 35S-PL 24, 28, 48 and 52; 35S-StPT2 26, 27 and 45; 35S-SAT 26 and 48, issued by the German Competent Authority
    Potato modified for increased tuber weight | Potato, SOLTU, Resistance to antibiotics, Changes in physiology and/or production | Potato modified for increased tuber weight | Potato, SOLTU, Resistance to antibiotics, Changes in physiology and/or production | Potato modified for increased specific density | Potato, SOLTU, Resistance to antibiotics, Changes in physiology and/or production | Potato modified for an enhanced phosphate content in leaves, roots and tubers | Potato, SOLTU, Resistance to antibiotics, Changes in physiology and/or production | Potato modified for reduced cell wall stability | Potato, SOLTU, Resistance to antibiotics, Changes in quality and/or metabolite content | Potato modified for tolerance to oxidative stress and heavy metals | Potato, SOLTU, Resistance to antibiotics, Tolerance to abiotic stress
Document on the decision, communication, notification or declaration
Additional Information
-  type of decision: field trial
-  LMO: 35S-alphaUMPS 21, 26, 29 and 73; B33-alphaUMPS 5, 8, 73 and 76; 35S-alphaAdK 4, 8, 20,24 and 28; 35S-StPT2 26, 27 and 45; 35S-PL 24, 28, 48 und 52; 35S-SAT 26 and 48
-  legal basis: Directive 90/220/EEC, Gentechnikgesetz (German Gene Technology Act)
-  scope: test of field performance of LMO
-  authorization valid from 11 May 1999 to 31 December 2002
-  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: 12 ha/site/yea
-  max. 4400 LMO/site

-  There is no Summary Notification Information Format available on the Internet (WebSNIF) for B/DE/99/103

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.
EN