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Country's Decision or any other Communication (DEC)
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BCH-DEC-DE-110667-4   |   PDF   |   Print   |  
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published: 04 Jul 2016 last updated: 15 Mar 2024
Amendment
No
General Information
6786-01-0189 (adv. 42010.0189); Decision regarding the riSsk assessment of a deliberate release (field trial) of the genetically modified black nightshade (Solanum nigrum L.) S06-336, S06-353, S06-354 and S06-356, issued by the German Competent Authority
EN
13 Aug 2007
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 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 label needs to distinctively describe the LMO and it needs to be noted that this black nightshade is unfit for consumption (food and feed). All remaining fertile plant material has to be destroyed by disruption of their germination capacity.
- Inspection of the LMOs at the release site on flower buds has to be accomplished every second day and the flower buds have to be removed and inactivated prior to pollination.
- After completion of the field trial an appropriate land management via harrowing and grubbing is intended to support fast germination of seeds so that transgenic nigtht shade volunteers can be easily destroyed.
- After completion of the field trial an inspection of the release site for one year on transgenic black nightshade volunteers, their removal and disposal has to be accomplished during the growing season periodically. The inspection period has to be extended for another year if black nightshade 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. Eine Entnahme durch Unbefugte ist nicht gestattet." (test plants not suitable for consumption, unauthorized removal is not permitted) has to be put up at the release site.
- Machines that have been in contact with LMOs have to be cleaned after use.
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-110660-4 Living Modified Organism Black nightshade modified for reduced production of endogenous proteinase inhibitors
    Max Planck Institute for Chemical Ecology(MPICE) | Resistance to antibiotics (Hygromycin), Resistance to diseases and pests (Insects)
  • BCH-RA-DE-110666-3 Risk Assessment generated by a regulatory process 6786-01-0189 (adv. 42010.0189); Summary of the risk assessment of a deliberate release (field trial) of the genetically modified black nightshade (Solanum nigrum L.) S06-336, S06-353, S06-354 and S06-356, issued by the German Competent Authority
    Black nightshade modified for reduced production of endogenous proteinase inhibitors | Black nightshade, SOLNI, Resistance to diseases and pests, Resistance to antibiotics
Document on the decision, communication, notification or declaration