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Country's Decision or any other Communication (DEC)
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BCH-DEC-DE-108794-3   |   PDF   |   Print   |  
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published: 23 Sep 2015 last updated: 05 Aug 2020
Amendment
No
General Information
6786-01-0205 (adv. 42010.0205); Decision regarding the deliberate release (field trial) of genetically modified potato (Solanum tuberosum) AM04-10120, issued by the German Competent Authority
EN
06 Apr 2010
No
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
some confinement measures:
- Fertile plant material (potato tuber) has to be transported and stored in closed and clearly labelled repositories at any time outside the release site and laboratory and has to kept separately from non transgenic potatoes. The label need 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 release site on unexpected biological traits of the LMO and reciprocal effects between LMO and other organisms has to be accomplished weekly during the experimental release and if required sufficient risk measures have to be performed.
- During and after the field trial monthly inspection of the surrounding area [10 m] of the release site for transgenic potato volunteers and their manual removal and disposal has to be accomplished. Fertile plant material has to be destroyed by disruption of their germination capacity.
- All transgenic potatoes that are not intended to be used for further cultivation or analysis as well as transgenic potatoes that are found when cleaning the working equipment have to be disposed by disruption of their germination capacity.
- After harvest and in the following spring the first 20 cm of the soil of the release site has to be loosen up and uncovered potatoes as well as potatoes that are found on the working equipment have to be collected and disposed by disruption of their germination capacity. The release site must not be ploughed.
- After completion of the field trial an inspection of the release site for one year on transgenic potato volunteers, their removal and disposal has to be accomplished during the growing season every 4 weeks. The inspection period has to be extended for another year if potato volunteers were observed. The release site must not be cultivated with plants impairing the detection of transgenic volunteers. If herbicides are used for control of second growth the timing of herbicide application should be chosen so that no daughter tubers survive.
- A sign indicating "Versuch mit gentechnisch veränderten Kartoffeln, die nicht als Lebensmittel oder Futtermittel zugelassen sind. Eine Entnahme durch Unbefugte ist nicht gestattet." (test with genetically modified potatoes, not authorized for use as food and feed, unauthorized removal is not permitted) has to be put up at the release site.
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-48075-7 Living Modified Organism BPS-A1Ø2Ø-5 - Amadea potato
    BASF Plant Science GmbH | Changes in quality and/or metabolite content (Amylose and amylopectin ratio), Resistance to herbicides (Imidazolinone, Sulfonylurea), Selectable marker genes and reporter genes
  • BCH-RA-DE-108793-3 Risk Assessment generated by a regulatory process 6786-01-0205 (adv. 42010.0205); Summary of the risk assessment of a deliberate release (field trial) of genetically modified potato (Solanum tuberosum) AM04-1020, issued by the German Competent Authority
    BPS-A1Ø2Ø-5 - Amadea potato | Potato, SOLTU, Resistance to herbicides, Changes in quality and/or metabolite content, Selectable marker genes and reporter genes
Document on the decision, communication, notification or declaration