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Country's Decision or any other Communication
Record information and status
Record ID
110966
Status
Published
Date of creation
2016-09-12 08:56 UTC (german_bch@bvl.bund.de)
Date of last update
2020-10-28 15:29 UTC (german_bch@bvl.bund.de)
Date of publication
2020-10-29 12:59 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
6786-01-0048 (adv. 42010.0048); Decision regarding the risk assessment of a deliberate release (field trial) of genetically modified Aspen (Populus tremula L. and P. tremula L. x P. tremuloides Michx.), different independent lines, issued by the German Competent Authority
Date of the decision
1996-05-28
Is the decision taken prior to entry into force of the Protocol?
Yes
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
BFH
Federal Research Centre for Forestry and Forest Products (BFH)
Institute of Wood Research
Leuschnerstraße 91
21031 Hamburg-Bergedorf

Institute of Forest Genetics
Sieker Landstraße 2
22927 Großhansdorf

Johann Heinrich von Thünen Institute
Federal Research Institute for Rural Areas, Forestry and Fisheries
Bundesallee 50
Brunschweig
Germany, 38116
Phone:+49 531 596 1003
Fax:+ 49 531 596 1099
Email:info@thuenen.de
Url:https://www.thuenen.de/en/about-us/history/bfh-forestry-and-forest-products/
Result of the decision
  • Approval of the import/use of the LMO(s) with conditions
Conditions
- Prior to and during the flowering time, the field site has to be inspected twice a week for flowering aspen. Trees which are developing flower buds are to be removed before flowering.
- After completion of the field trial the release site and a surrounding area of 15 m have to be inspected for remaining roots for two years and developing basal shoots. Plant material that remains on the release site after the harvest has to be removed and destroyed by chopping or chemical treatment. If transgenic aspen volunteers emerge in the last year of inspection, the inspection period is to be extended for another year.
- No plant species must be cultivated on the release site that impairs the detection of transgenic aspen volunteers.

Reasons
To comply with requirements of Directive 90/220/EEC, 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
Hybrid Aspen, female, modified for an altered morphology and reduced growth
BFH Changes in physiology and/or production Resistance to antibiotics - Kanamycin
Hybrid Aspen, female, modified for an altered morphology
BFH Changes in physiology and/or production Resistance to antibiotics - Kanamycin
Aspen, female, modified for modified for an altered morphology and reduced growth
BFH Changes in physiology and/or production Resistance to antibiotics - Kanamycin
Aspen, male, modified for modified for an altered morphology and reduced growth.
BFH Changes in physiology and/or production Resistance to antibiotics - Kanamycin
Risk assessment
6786-01-0048 (adv. 42010.0048); Summary of the risk assessment of a deliberate release (field trial) of genetically modified Aspen (Populus tremula L. and P. tremula L. x P. tremuloides Michx.), different independent lines, issued by the German Competent Authority
Hybrid Aspen, female, modified for an altered morphology and reduced growth
BFH

Changes in physiology and/or production
Resistance to antibiotics - Kanamycin
Hybrid Aspen, female, modified for an altered morphology
BFH

Changes in physiology and/or production
Resistance to antibiotics - Kanamycin
Aspen, female, modified for modified for an altered morphology and reduced growth
BFH

Changes in physiology and/or production
Resistance to antibiotics - Kanamycin
Aspen, male, modified for modified for an altered morphology and reduced growth.
BFH

Changes in physiology and/or production
Resistance to antibiotics - Kanamycin
Additional Information
Additional Information
-  type of decision: field trial
-  LMO: differnt independent lines expressing the rolC gene from Agrobacterium rhizogenes
-  legal basis: Directive 90/220/EEC, Gentechnikgesetz (German Gene Technology Act)
-  scope: test of field performance of LMO
-  authorization valid from 28 May 1996 to 31 December 2001
-  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: 1500 m²/site/year
-  max. 480 LMO/site

-  There is no Summary Notification Information Format available on the Internet (WebSNIF) for B/DE/96/48

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.