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Country's Decision or any other Communication
(DEC)
published: 28 Sep 2015
last updated: 15 Mar 2024
No
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
EN
02 Jun 2005
No
- Decision on LMOs for intentional introduction into the environment (according to Article 10 or domestic regulatory framework)
No
No
-
Organization:Max Planck Institute for Chemical Ecology (MPICE)Academic or research instituteHans-Knöll-Strasse 8Jena,
07745, GermanyPhone: +49 3641 57-0,Fax: +49 3641 57-1002,Email: info@ice.mpg.de,Website: https://www.ice.mpg.de,
Yes
No
No
Approval of the import and/or use of the LMO(s) with 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.
EN
- 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.
To comply with requirements of Directive 2001/18/EC, Gentechnikgesetz (German Gene Technology Act): reduce possibility of GMO spread/establishment.
EN
-
BCH-LMO-SCBD-108714-3 Living Modified Organism Black Nightshade with reduced pathogenesis-related protein 1S synthesisMax Planck Institute for Chemical Ecology(MPICE) | Resistance to antibiotics (Hygromycin), Resistance to diseases and pests
-
BCH-LMO-SCBD-108713-3 Living Modified Organism Black Nightshade with reduced pathogenesis-related protein 1S synthesis.Max Planck Institute for Chemical Ecology(MPICE) | Resistance to antibiotics (Hygromycin), Resistance to diseases and pests
-
BCH-RA-DE-108796-3 Risk Assessment generated by a regulatory process 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 AuthorityBlack Nightshade with reduced pathogenesis-related protein 1S synthesis | Black nightshade, SOLNI, Resistance to diseases and pests, Resistance to antibiotics | Black Nightshade with reduced pathogenesis-related protein 1S synthesis. | Black nightshade, SOLNI, Resistance to diseases and pests, Resistance to antibiotics
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)
EN
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)
- Summary Notification Information Format available on the Internet (WebSNIF) [ English ]
- Summary Notification Information Format erhältlich im Internet (WebSNIF) (nur in englischer Sprache) [ German ]
- BVL German LMO/GMO location register [ English ]
- Deutsches GVO-Standortregister des BVL [ German ]
- 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 (courtesy translation; only the German text is authentic) [ English ]
- 6786-01-0164 (bzw. 42010.0164); Zusammenfassung der Risikobewertung eines Freisetzungsvorhabens (Feldversuch) mit gentechnisch verändertem Schwarzen Nachtschatten (Solanum nigrum L.) S03/140-5 und S03/144-2, erstellt durch die deutsche zuständige Behörde [ German ]
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