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Country's Decision or any other Communication
Record information and status
Record ID
110834
Status
Published
Date of creation
2016-08-22 08:51 UTC (german_bch@bvl.bund.de)
Date of last update
2020-09-28 13:26 UTC (german_bch@bvl.bund.de)
Date of publication
2020-09-29 06:22 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
6786-01-0061 (adv. 42010.0061); Decision regarding the risk assessment of a deliberate release (field trial) of the genetically modified oilseed rape plants (Brassica napus L.), offspring of the F1 hybrid 23-198, issued by the German Competent Authority
Date of the decision
1997-03-25
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
NPZ
Norddeutsche Pflanzenzucht
Hans-Georg Lembke KG
Hohenlieth
24363 Holtsee
Holtsee
Germany, 24363
Phone:+49 4351 736 0
Fax:+49 4351 736 295
Email:info@npz.de
Url:Norddeutsche Pflanzenzucht
Result of the decision
  • Approval of the import/use of the LMO(s) with conditions
Conditions
-  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 be kept separately from non-transgenic plant material.
-  All remaining fertile plant material has to be destroyed by disruption of their germination capacity.
-  The release site has to be surrounded by shelter-crops (6 m) and a 50 m isolation area, or a 100 m isolation area without shelter-crops.
-  Plant material that remains on the release site after the harvest has to be removed and destroyed by chopping or chemical treatment.
-  After completion of the field trial the release site and a surrounding area of 10 m have to be inspected for transgenic oilseed rape volunteers
-  No plant species must be cultivated on the release site that impairs the detection of transgenic oilseed rape 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
CGN-89465-2 - High oleic acid canola
Production of medical or pharmaceutical compounds (human or animal) - Omega-3 fatty acids (e.g. DHA) Resistance to antibiotics - Kanamycin
Risk assessment
6786-01-0061 (adv. 42010.0061); Summary of the risk assessment of a deliberate release (field trial) of the genetically modified oilseed rape (Brassica napus L.), offspring of the F1 hybrid 23-198 (Event 23), issued by the German Competent Authority
CGN-89465-2 - High oleic acid canola
Production of medical or pharmaceutical compounds (human or animal) - Omega-3 fatty acids (e.g. DHA)
Resistance to antibiotics - Kanamycin
Additional Information
Additional Information
The LMO released here is the offspring of a F1 hybrid of 23-198 (Event 23, UID: CGN-89465-2; see BCH record 14782). While the original transformant (Event 23) was estimated to have 15 copies of the T-DNA integrated at 5 independent loci in the genome, the F1 hybrid only has integrated 4 to 6 copies.

-  type of decision: field trial
-  LMO: progeny of the F1 hybrid 23-198
-  legal basis: Directive 90/220/EEC, Gentechnikgesetz (German Gene Technology Act)
-  scope: test of field performance of LMO
-  authorization valid from 25 March 1997 to 31 December 2002
-  locations: 10 experimental fields located in 9 villages 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: 34000 m²/site/year
-  max. 1 million LMO/site/year

-  There is no Summary Notification Information Format available on the Internet (WebSNIF) for B/DE/97/61