Germany | BCH-DEC-DE-111649 | Country's Decision or any other Communication | Biosafety Clearing-House

Loading...
  |  

Country's Decision or any other Communication (DEC)

last updated: 05 Nov 2020
Amendment
No
General information
6786-01-0041 (adv. 42010.0041); Decision regarding the risk assessment of a deliberate release (field trial) of genetically modified tobacco (Nicotiana tabacum L.) XynZ No 34 and XynZ No 46, issued by the German Competent Authority
EN
04 Apr 1996
Yes
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
If the tobacco plants are left to flower, a 200 m distance has to be kept to other flowering tobacco plants. Inflorescences removed from the transgenic plants have to be kept safe from insects and destroyed.
EN
To comply with requirements of Directive 90/220/EEC, Gentechnikgesetz (German Gene Technology Act): reduce possibility of GMO spread/establishment.
EN
LMO identification & risk assessment
  • BCH-LMO-SCBD-111621-1 Living Modified Organism Tobacco modified for xylanase production
    Institut für Pflanzengenetik und Kulturpflanzenforschung | Resistance to antibiotics (Kanamycin, Neomycin), Use in industrial applications
  • BCH-RA-DE-111648-3 Risk Assessment generated by a regulatory process 6786-01-0041 (adv. 42010.0041); Summary of the risk assessment of a deliberate release (field trial) of genetically modified tobacco (Nicotiana tabacum L.) XynZ No 34 and XynZ No 46, issued by the German Competent Authority
    Tobacco modified for xylanase production | Resistance to antibiotics, Use in industrial applications
Document on the decision, communication, notification or declaration
Additional Information
-  type of decision: field trial
-  LMO:  XynZ No 34 und XynZ No 46
-  legal basis: Directive 90/220/EEC, Gentechnikgesetz (German Gene Technology Act)
-  scope: test of field performance of LMO
-  authorization valid from 04 April 1996 to 31 December 1997
-  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: 575 m²/site/year;
-  max. 400 LMO/site/year

-  There is no Summary Notification Information Format available on the Internet (WebSNIF) B/DE/96/41

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.
Records referencing this document Show in search
Record type Field Record(s)