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Decisión o cualquier otra comunicación de un país (DEC)
  |  
BCH-DEC-DE-111115-4   |   PDF   |   Imprimir   |  
published: 26 oct. 2016 last updated: 15 mar. 2024
Enmienda
No
Información general
6786-01-0124 (adv. 42010.0124); Decision regarding the risk assessment of a deliberate release (field trial) of genetically modified potato (Solanum tuberosum L.), 10 independent lines (35S-alphaTS, 35S-alphaPGMI, 35S-alphaPGMI-II), issued by the German Competent Authority
EN
24 abr. 2001
Tema de la decisión, notificación, comunicación o declaración
  • Decisión sobre OVM para introducción intencional en el medio ambiente (de conformidad con el artículo 10 sobre el marco reglamentario nacional)
OVM para su introducción intencional en el medio ambiente
No
No
No
No
Resultado de la decisión
Aprobación de la importación y/o uso del/de los OVM con condiciones
-  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 field site needs to be labeled, stating that this potato is unfit for consumption.
-  All remaining fertile plant material has to be destroyed by disruption of their germination capacity.
-  All machines that have been used on the release site have to be thoroughly cleaned on the release site.
-  After harvest and in the following year, the first 15 - 20 cm of upper soil of the release site have to be loosened up. Potato tubers that emerge during that procedure have to be manually collected, removed, and destroyed by disruption of their germination capacity.
-  Following the deliberate release, the release site must be inspected for transgenic volunteer potatos at least once every four weeks. The inspection period has to be extended for another year if potato volunteers were observed. No plant species must be cultivated on the release site that impairs the detection of transgenic potato volunteers.
EN
To comply with requirements of Directive 2001/18/EC, Gentechnikgesetz (German Gene Technology Act): reduce possibility of GMO spread/establishment.
EN
Identificación y evaluación del riesgo del OVM
  • BCH-LMO-SCBD-111086-2 Organismos vivos modificados Potato modified for increased methionine content in leaves and tubers
    Max Planck Institute of Molecular Plant Physiology(MPIMP) | Cambios en la calidad y/o el contenido metabólico (Proteínas y aminoácidos), Resistencia a los antibióticos (Kanamicina)
  • BCH-LMO-SCBD-111089-2 Organismos vivos modificados Potato modified for altered starch content
    Max Planck Institute of Molecular Plant Physiology(MPIMP) | Cambios en la calidad y/o el contenido metabólico (Carbohidratos), Resistencia a los antibióticos (Kanamicina)
  • BCH-LMO-SCBD-111090-2 Organismos vivos modificados Potato modified for altered starch content
    Max Planck Institute of Molecular Plant Physiology(MPIMP) | Cambios en la calidad y/o el contenido metabólico (Carbohidratos), Resistencia a los antibióticos (Kanamicina)
  • BCH-RA-DE-111114-3 Evaluación del riesgo generada por un proceso regulatorio 6786-01-0124 (adv. 42010.0124); Summary of the risk assessment of a deliberate release (field trial) of genetically modified potato (Solanum tuberosum L.), 10 independent lines (35S-alphaTS, 35S-alphaPGMI, 35S-alphaPGMI-II), issued by the German Competent Authority
    Potato modified for increased methionine content in leaves and tubers | Potato, SOLTU, Resistencia a los antibióticos, Cambios en la calidad y/o el contenido metabólico | Potato modified for altered starch content | Potato, SOLTU, Resistencia a los antibióticos, Cambios en la calidad y/o el contenido metabólico | Potato modified for altered starch content | Potato, SOLTU, Resistencia a los antibióticos, Cambios en la calidad y/o el contenido metabólico
Documentación sobre la decisión, comunicación, notificación o declaración
Información adicional
-  type of decision: field trial
-  LMO: 10 independent lines (35S-alphaTS, 35S-alphaPGMI, 35S-alphaPGMI-II
-  legal basis: Directive 2001/18/EC, Gentechnikgesetz (German Gene Technology Act)
-  scope: test of field performance of LMO
-  authorization valid from 24 April 2001 to 31 December 2003
-  locations: 1 experimental field located in 1 village in Germany, for details refer to the German LMO/GMO location register (https://apps2.bvl.bund.de/stareg_web/localeSwitch.do?language=en&page=/showflaechen.do?)
-  size: 7.7 ha/site/year
-  max. 2000 LMO/site/year

-  There is no Summary Notification Information Format available on the Internet (WebSNIF) for B/DE/01/124

The decision on this deliberate release was made by the Robert Koch Institute (RKI).
The RKI was the competent national authority for the German Gene Technology Act before the competences were transferred to the Federal Office of Consumer Protection and Food Safety (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, BVL) on April 1st 2004. Deliberate releases that were authorized by the RKI prior to this date are now handled by the BVL.
EN