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Country's Decision or any other Communication
Record information and status
Record ID
108797
Status
Published
Date of creation
2015-09-28 14:22 UTC (german_bch@bvl.bund.de)
Date of last update
2017-04-12 14:02 UTC (german_bch@bvl.bund.de)
Date of publication
2017-05-16 11:19 UTC (222@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
6786-01-0164 (adv. 42010.0164); Decision regarding the deliberate release (field trial) of genetically modified black nightshade (Solanum nigrum L.) S03/140-5 and S03/144-2, issued by the German Competent Authority
Date of the decision
2005-06-02
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
- The specification of the exact release site.
- If any new information on the cultivated LMO emerges that might bear any risk for human health, animal health or the environment the national federal authority needs to be informed and sufficient risk measures have to be performed.
- Machines and transportation containers that have been in contact with LMOs have to be cleaned thoroughly after use to minimize unintended transfer of genetically modified seeds.
- 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.
- If plant material will be stored outside a genetic engineering facility the national federal authority needs to be informed about location and expected period a priori.
- Inspection of the LMOs at the release site on flower buds has to be accomplished daily and the flower buds have to be removed and inactivated prior to pollination.
- During the release period the surrounding area of the release site (35 m) has to be inspected for Solanum nigrum plants and also other Solanum species (S. nigrum ssp. schultesii, S physalifolium var. nitidibaccatum, S. sarrachoides, S. villosum, S. tuberosum, S. dulcamara und Lycopersicon esculentum) which have to be removed and disposed.
- 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. Transgenic plants have to be removed before flowering. The inspection period has to be extended for another year if black nightshade volunteers were observed.
- A sign indicating "Versuchspflanzen, nicht zum Verzehr geeignet" (test plants not suitable for consumption) has to be put up at the release site.
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 with reduced pathogenesis-related protein 1S synthesis
Resistance to antibiotics - Hygromycin Resistance to diseases and pests Selectable marker genes and reporter genes
Black Nightshade with reduced pathogenesis-related protein 1S synthesis.
Resistance to antibiotics - Hygromycin Resistance to diseases and pests Selectable marker genes and reporter genes
Risk assessment
6786-01-0164 (adv. 42010.0164); Summary of the risk assessment of a deliberate release (field trial) of the genetically modified black nightshade (Solanum nigrum L.) S03/140-5 and S03/144-2 issued by the German Competent Authority
Black Nightshade with reduced pathogenesis-related protein 1S synthesis
Resistance to antibiotics - Hygromycin
Resistance to diseases and pests
Selectable marker genes and reporter genes
Black Nightshade with reduced pathogenesis-related protein 1S synthesis.
Resistance to antibiotics - Hygromycin
Resistance to diseases and pests
Selectable marker genes and reporter genes
Additional Information
Additional Information
type of decision: field trial
LMO: Black Nightshade (Solanum nigrum L.) S03/140-5 and S03/144-2
legal basis: Directive 2001/18/EC, Gentechnikgesetz (German Gene Technology Act)
scope: test of field performance of LMO
authorization valid from 02/06/2005 to 31/12/2007
locations: 1 experimental field located in 1 village in Germany; for details see German LMO/GMO location register ( http://apps2.bvl.bund.de/stareg_web/localeSwitch.do?language=en&page=/showflaechen.do?)
size: 10.000 m²/site/year; max. 600 LMO/site/year; 2 plants/m² (1 LMO, 1 wildtype)