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Country's Decision or any other Communication (DEC)
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BCH-DEC-DE-101216-3   |   PDF   |   Print   |  
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published: 02 Jun 2010 last updated: 11 Jun 2020
Amendment
No
General Information
6786-01-0186 (adv. 42010-0186); Decision regarding the risk assessment of a deliberate release (field trial) of genetically modified potato (Solanum tuberosum L.) EH92-527-1 (BPS-25271-9), issued by the German Competent Authority
EN
25 May 2007
No
Subject of the decision, notification, communication or declaration
  • Decision on LMOs for intentional introduction into the environment (according to Article 10 or domestic regulatory framework)
LMOs for intentional introduction into the environment
No
No
Yes
No
No
Result of the decision
Approval of the import and/or use of the LMO(s) with conditions
some confinement measures:
• storage of seed potatoes isolated from non-gmo potatoes
• isolation distance to non-gmo potato fields: minimum 10 m
• area 10 m surrounding the field trial must be controlled min. 1/month on occurrence of gentically modified potatoes, these must be destroyed.
• frequent control of the field trial minimum 1/week
• fertile plant material must be carried in closed and clearly marked repositories
• machines in contact with LMO must be cleaned after use
• remaining fertile plant material must be destroyed in a way that impedes germination.
• after harvest and in spring of the following year the soil of the release site must be harrowed to 10-20 cm depth, appearing potato tubers must be collected manually and destroyed.
• control of release site and surrounding area for volunteers 1 year after end of experiments, volunteers and tubers have to be destroyed, in case volunteer LMO potatoes appear during the control period this is extended for another year
note: not for food or feed purposes
EN
to comply with requirements of Directive 2001/18/EC, Gentechnikgesetz [German Gene Technology Act]:
reduce possibility of GMO spread
EN
LMO identification & risk assessment
  • BCH-LMO-SCBD-15100-7 Living Modified Organism BPS-25271-9 - Amflora™Potato
    Reduced amylose in starch content, Resistance to antibiotics (Kanamycin)
  • BCH-RA-DE-101210-4 Risk Assessment generated by a regulatory process 6786-01-0186 (adv. 42010.0186); Summary of the risk assessment of a deliberate release (field trial) of genetically modified potatoes (Solanum tuberosum) "EH92-527-1" (BPS-25271-9), issued by the German Competent Authority
    BPS-25271-9 - Amflora™Potato | Potato, SOLTU, Resistance to antibiotics
Document on the decision, communication, notification or declaration
Additional Information
type of decision: field trial
LMO: EH92-527-1 (BPS-25271-9)
legal basis: Directive 2001/18/EC, Gentechnikgesetz [German Gene Technology Act]
scope: test of field performance of LMO
authorization valid from 25 Mai 2007 to 31 December 2008
locations: experimental fields located in 3 different 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: 250.000 m²/site/year
app. 45.000 plants/ha)

- There is a Summary Notification Information Format (WebSNIF) available on the internet for B/DE/06/186
EN