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Country's Decision or any other Communication
Record information and status
Record ID
110669
Status
Published
Date of creation
2016-07-04 11:16 UTC (german_bch@bvl.bund.de)
Date of last update
2020-08-06 13:14 UTC (german_bch@bvl.bund.de)
Date of publication
2020-08-07 05:50 UTC (nina.opitz@bmel.bund.de)

This document is also available in the following languages:
General information
Country submitting the decision or communication
  • Germany
Competent National Authority(ies) responsible for the decision or communication
Federal Office of Consumer Protection and Food Safety
Mauerstrasse 39-42
Berlin
Germany, 10117
Phone:+49-(0)3018-445-6500
Fax:+49-(0)3018-445-6099
Email:german_bch@bvl.bund.de
Url:http://www.biosafety-bch.de (english language),BVL Homepage (English)
Title / Reference number of the decision or communication
6786-01-0188 (adv. 42010.0188); Decision regarding a deliberate release (field trial) of the genetically modified black nightshade (Solanum nigrum L.) S03/71 and S03/82, issued by the German Competent Authority
Date of the decision
2007-07-20
Is the decision taken prior to entry into force of the Protocol?
No
Jurisdiction
  • Germany
Is this an amendment to a previous decision / communication?
No
Decision or communication details
Subject(s) of the decision
  • Decision on LMOs for intentional introduction into the environment (according Article 10 or domestic regulatory framework)
Was the decision triggered by a request for a transboundary movement of LMOs into the country?
No
Does the decision apply to transboundary movements of LMO(s) into the country?
No
Importer’s or Applicant’s contact details
Max-Planck-Institut für Chemische Ökologie
Hans-Knöll-Strasse 8
D-07745 Jena
Germany
Result of the decision
  • Approval of the import/use of the LMO(s) with conditions
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.
Reasons
To comply with requirements of Directive 2001/18/EC, Gentechnikgesetz (German Gene Technology Act): reduce possibility of GMO spread/establishment.
Does the decision involve field trials?
Yes
Does the decision involve commercial release?
No
LMO identification
Black nightshade modified for reduced production of endogenous prosystemin
Resistance to antibiotics - Hygromycin Resistance to diseases and pests Selectable marker genes and reporter genes
Risk assessment
6786-01-0188 (adv. 42010.0188); Summary of the risk assessment of a deliberate release (field trial) of the genetically modified black nightshade (Solanum nigrum L.) S03/71 and S03/82, issued by the German Competent Authority
Black nightshade modified for reduced production of endogenous prosystemin
Resistance to antibiotics - Hygromycin
Resistance to diseases and pests
Selectable marker genes and reporter genes