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Country's Decision or any other Communication
Record information and status
Record ID
102929
Status
Published
Date of creation
2011-12-08 10:22 UTC (german_bch@bvl.bund.de)
Date of last update
2017-05-23 12:38 UTC (german_bch@bvl.bund.de)
Date of publication
2017-07-13 15:40 UTC (ursula.monnerjahn@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
6786-01-0162 (adv. 42010.0162); Decision regarding the deliberate release of genetically modified potato (Solanum tuberosum; Seresta, Kuras) AM02-1003, AM02-1005, AM02-1008, AM02-1010, AM02-1012, AM02-1014 and AM02-1017 issued by the German Competent Authority
Date of the decision
2005-04-15
Is the decision taken prior to entry into force of the Protocol?
No
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
BASF Plant Science GmbH
Carl-Bosch-Str. 38
Ludwigshafen
Germany, 67056
Phone:+49 621 60-0
Fax:+49 621 60-42525
Email:global.info@basf.com
Url:BASF AG - Pflanzenbiotechnologie
Result of the decision
  • Approval of the import/use of the LMO(s) with conditions
Conditions
- If any new information on the cultivated LMO emerges that might bear any risk for human health, animal health or the environment the national federal authority needs to be informed.
- Fertile plant material (potato tuber) has to be transported and stored in closed and clearly labelled repositories at any time outside the release site. The label need to distinctively describe the LMO and it needs to be noted that this potato is unfit for consumption. All remaining fertile plant material has to be destroyed by disruption of their germination capacity, e.g. via fermentation within a biogas plant.
- Inspection of the release site on unexpected biological traits of the LMO and on disturbance by wildlife has to be accomplished every four weeks during the experimental release and sufficient risk measures have to be performed.
- After completion of the field trial the soil of the release site has to be loosen up (first 20 cm of the soil) but not to be ploughed. Uncovered potato tubers have to be collected by hand and destroyed as previously described.
- After completion of the field trial an inspection every four weeks of the release site for transgenic potato volunteers, their documentation and removal and disposal has to be accomplished during the growing season or if volunteers were observed for one year longer if volunteers were observed. The release site must not be cultivated with plants impairing the detection of transgenic volunteers. 
Reasons
To comply with requirements of Directive 2001/18/EC, 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 with altered starch composition
BASF Plant Science GmbH altered carbohydrate composition: increased amylopectin content Resistance to herbicides - Imidazolinone, Sulfonylurea
Show detection method(s)
Risk assessment
6786-01-0162; Summary of the risk assessment of a deliberate release (field trial) of genetically modified potato (Solanum tuberosum; Seresta, Kuras) AM02-1003, AM02-1005, AM02-1008, AM02-1010, AM02-1012, AM02-1014 and AM02-1017 issued by the German Competent Authority
Potato with altered starch composition
BASF Plant Science GmbH

altered carbohydrate composition: increased amylopectin content
Resistance to herbicides - Imidazolinone, Sulfonylurea
Additional Information
Additional Information
- type of decision: field trail
- LMO: AM02-1003, AM02-1005, AM02-1008, AM02-1010, AM02-1012, AM02-1014, AM02-1017
- legal basis: Directive 2001/18/EC, Gentechnikgesetz (German Gene Technology Act)
- scope: test of field performance of LMO
- authorization valid from 01/01/2005-31/12/2009
- locations: 3 experimntal fields located in 3 different villages in Germany, for details see German LMO/GMO location register (German language only) (http://apps2.bvl.bund.de/stareg_web/showflaechen.do)
- size:
(1) 46 ha in Sanitz, release between 07/06/2005 and 20/10/2005
(2) 0.5 ha in Lohmen, release between 08/06/2005 and 19/10/2005
(3) 5.04 ha in Werpeloh, release between 09/06/2005 and 27/10/2005
- max. 3000 LMO per line and site in agreement with agronomic practice

- There is a Summary Notification Information Format available on the Internet (WebSNIF) for B/DE/04/162

   
   
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