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Country's Decision or any other Communication
Record information and status
Record ID
110970
Status
Published
Date of creation
2016-09-13 10:24 UTC (german_bch@bvl.bund.de)
Date of last update
2020-10-28 15:33 UTC (german_bch@bvl.bund.de)
Date of publication
2020-10-29 13:01 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
6786-01-0057 (adv. 42010-0057); Decision regarding the risk assessment of a deliberate release (field trial) of genetically modified oilseed rape plants (Brassica napus L.), different independent lines with an altered storage lipid composition, issued by the German Competent Authority
Date of the decision
1997-03-27
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 to 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
DSV
Deutsche Saatveredelung AG (DSV)
Weissenburger Straße 5
59557 Lippstadt
Lippstadt
Germany, 59557
Phone:+49 2941 2960
Fax:+49 2941 296100
Email:info@dsv-saaten.de
Url:https://www.dsv-saaten.de/
Result of the decision
  • Approval of the import and/or 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.
-  Machines that have been in contact with LMOs have to be cleaned after use.
-  The release site has to be surrounded by 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.
-  The inspection period has to be extended for another year if transgenic oilseed rape volunteers were observed in the last year of the inspection period.
-  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
Brassica napus modified for altered fatty acid metabolism
BAZ Changes in quality and/or metabolite content - Lipid and fatty acids Resistance to antibiotics - Kanamycin
Oilseed rape modified for an altered fatty acid metabolism in the seeds
DSV Changes in quality and/or metabolite content - Lipid and fatty acids Resistance to antibiotics - Kanamycin
Oilseed rape modified for increased myristic acid content in the seeds
DSV Changes in quality and/or metabolite content - Lipid and fatty acids Resistance to antibiotics - Kanamycin
Oilseed rape modified for increased oleic acid content in the seeds
DSV Changes in quality and/or metabolite content - Lipid and fatty acids Resistance to antibiotics - Kanamycin
Risk assessment
6786-01-0057 (adv. 42010.0057); Summary of the risk assessment of a deliberate release (field trial) of genetically modified oilseed rape (Brassica napus L.), different independend lines with an altered storage lipid composition, issued by the German Competent Authority
Brassica napus modified for altered fatty acid metabolism
BAZ

Changes in quality and/or metabolite content - Lipid and fatty acids
Resistance to antibiotics - Kanamycin
Oilseed rape modified for an altered fatty acid metabolism in the seeds
DSV

Changes in quality and/or metabolite content - Lipid and fatty acids
Resistance to antibiotics - Kanamycin
Oilseed rape modified for increased myristic acid content in the seeds
DSV

Changes in quality and/or metabolite content - Lipid and fatty acids
Resistance to antibiotics - Kanamycin
Oilseed rape modified for increased oleic acid content in the seeds
DSV

Changes in quality and/or metabolite content - Lipid and fatty acids
Resistance to antibiotics - Kanamycin
Additional Information
Additional Information
-  type of decision: field trial
-  LMO: different independent lines transformed with pNBM99-ClFatB4, pNBM99-EnClFatB4, pRE1-E12, pRESS and/or pNAT4
-  legal basis: Directive 90/220/EEC, Gentechnikgesetz (German Gene Technology Act)
-  scope: test of field performance of LMO
-  authorization valid from 27 March 1997 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?)

-  There is no Summary Notification Information Format available on the Internet (WebSNIF) for B/DE/97/57

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.

   
   
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