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Country's Decision or any other Communication
Record information and status
Record ID
111651
Status
Published
Date of creation
2017-02-07 08:18 UTC (german_bch@bvl.bund.de)
Date of last update
2020-11-23 12:16 UTC (german_bch@bvl.bund.de)
Date of publication
2020-11-23 16:01 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
6786-01-0103 (adv. 42010.0103); Decision regarding the risk assessment of a deliberate release (field trial) of genetically modified potato (Solanum tuberosum L.), 35S-alphaUMPS 21, 26, 29 and 73; B33-alphaUMPS 5, 8, 73 and 76; 35S-alphaAdK 4, 8, 20,24 and 28; 35S-StPT2 26, 27 and 45; 35S-PL 24, 28, 48 and 52; 35S-SAT 26 and 48, issued by the German Competent Authority
Date of the decision
1999-05-11
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
Max Planck Institute of Molecular Plant Physiology (MPIMP)
Max-Planck-Institut für Molekulare Pflanzenphysiologie
Am Mühlenberg 1
Potsdam
Germany, 14476
Phone:+49 331 567 - 80
Fax:+49 331 567 - 84 08
Email:contact@mpimp-golm.mpg.de
Url:Max-Planck-Institut für Molekulare Pflanzenphysiologie
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. The label needs to distinctively describe the identity of the LMO.
- All machines that have been used on the release site have to be thoroughly cleaned on the release site.
- All remaining fertile plant material has to be destroyed by disruption of its germination capacity.
-  The field site has to be surrounded by a fence with a label stating that these potatoes are unfit for consumption.
-  After harvest and in the following year, the first 15 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. The release site must not be ploughed after harvest of the potato tubers.
-  The release site must be inspected for transgenic volunteer potatoes at least once every four weeks. Potato tubers that emerge during that procedure have to be collected, removed, and destroyed by disruption of their germination capacity. If more than five genetically modified potatoes emerge per 150 m2 inspection of the release site has to be extended for one year. During the inspection period no plants must be cultivated that impair the detection of transgenic potato 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
Potato modified for increased tuber weight
Changes in physiology and/or production - Yield Resistance to antibiotics - Kanamycin
Potato modified for increased tuber weight
Changes in physiology and/or production - Yield Resistance to antibiotics - Kanamycin
Potato modified for increased specific density
Changes in physiology and/or production - Yield Resistance to antibiotics - Kanamycin
Potato modified for an enhanced phosphate content in leaves, roots and tubers
Changes in physiology and/or production Changes in quality and/or metabolite content Resistance to antibiotics - Kanamycin
Potato modified for reduced cell wall stability
Changes in physiology and/or production Resistance to antibiotics - Hygromycin Selectable marker genes and reporter genes
Potato modified for tolerance to oxidative stress and heavy metals
Changes in quality and/or metabolite content - Antioxidants Resistance to antibiotics - Hygromycin Selectable marker genes and reporter genes Tolerance to abiotic stress
Risk assessment
6786-01-0103 (adv. 42010.0103); Summary of the risk assessment of a deliberate release (field trial) of genetically modified potato (Solanum tuberosum L.) 35S-alphaUMPS 21, 26, 29 and 73; B33-alphaUMPS 5, 8, 73 and 76; 35S-alphaAdK 4, 8, 20,24 and 28; 35S-PL 24, 28, 48 and 52; 35S-StPT2 26, 27 and 45; 35S-SAT 26 and 48, issued by the German Competent Authority
Potato modified for increased tuber weight
Changes in physiology and/or production - Yield
Resistance to antibiotics - Kanamycin
Potato modified for increased tuber weight
Changes in physiology and/or production - Yield
Resistance to antibiotics - Kanamycin
Potato modified for increased specific density
Changes in physiology and/or production - Yield
Resistance to antibiotics - Kanamycin
Potato modified for an enhanced phosphate content in leaves, roots and tubers
Changes in physiology and/or production
Changes in quality and/or metabolite content
Resistance to antibiotics - Kanamycin
Potato modified for reduced cell wall stability
Changes in physiology and/or production
Resistance to antibiotics - Hygromycin
Selectable marker genes and reporter genes
Potato modified for tolerance to oxidative stress and heavy metals
Changes in quality and/or metabolite content - Antioxidants
Resistance to antibiotics - Hygromycin
Selectable marker genes and reporter genes
Tolerance to abiotic stress
Additional Information
Additional Information
-  type of decision: field trial
-  LMO: 35S-alphaUMPS 21, 26, 29 and 73; B33-alphaUMPS 5, 8, 73 and 76; 35S-alphaAdK 4, 8, 20,24 and 28; 35S-StPT2 26, 27 and 45; 35S-PL 24, 28, 48 und 52; 35S-SAT 26 and 48
-  legal basis: Directive 90/220/EEC, Gentechnikgesetz (German Gene Technology Act)
-  scope: test of field performance of LMO
-  authorization valid from 11 May 1999 to 31 December 2002
-  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: 12 ha/site/yea
-  max. 4400 LMO/site

-  There is no Summary Notification Information Format available on the Internet (WebSNIF) for B/DE/99/103

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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