Germany | BCH-DEC-DE-101206 | Country's Decision or any other Communication | Biosafety Clearing-House

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BCH-DEC-DE-101206-5   |   PDF   |   Print   |  

Country's Decision or any other Communication (DEC)

published: 28 May 2010 last updated: 23 Nov 2020
Amendment
No
General Information
6782-01-0157 (adv. 42010.0157); Decision regarding the deliberate release (field trial) of genetically modified potato (Solanum tuberosum) "B33-Apy1-RNAi 1331" (3 lines), issued by the German Competent Authority
EN
22 Mar 2005
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
- 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 [30 m] of the release site for transgenic potato volunteers and their manual removal and disposal has to be accomplished.
- 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. If experimental release involved overwinter survival trials inspection of the release site has to be performed from May to December after harvest. 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.
- A sign indicating " Versuchspflanzen, nicht zum Verzehr geeignet" (test plants, not authorized for use as food) 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-100277-7 Living Modified Organism Potato with altered growth and tuber quality
    Other growth, development and product quality, Resistance to antibiotics (Kanamycin)
  • BCH-RA-DE-49377-7 Risk Assessment generated by a regulatory process 6786-01-0157 (adv. 42010.0157); Summary of the risk assessment of a deliberate release (field trial) of genetically modified potatoes (Solanum tuberosum; Desireé) B33-Apy1-RNAi 1331 (3 lines), issued by the German Competent Authority
    Potato with altered growth and tuber quality | Potato, SOLTU, Resistance to antibiotics, Changes in physiology and/or production
Document on the decision, communication, notification or declaration
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