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Country's Decision or any other Communication (DEC)
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BCH-DEC-DE-103047-3   |   PDF   |   Print   |  
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published: 25 Jan 2012 last updated: 27 Jul 2020
Amendment
No
General Information
6786-01-0182 (adv. 42010.0182); Decision regarding the deliberate release (field trial) of genetically modified pea (Pisum sativum, cultivar: Eiffel) BA11-2, issued by the German Competent Authority
EN
25 Sep 2006
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
- Fertile plant material (peas) has to be transported and stored in closed and clearly labelled repositories at any time outside the release site and laboratory. The label needs to distinctively describe the LMO and it needs to be noted that these peas are unfit for consumption. All remaining fertile plant material has to be destroyed by disruption of the germination capacity.
- Inspection of release site on unexpected biological traits of the LMO and reciprocal effects between LMO and other organisms has to be accomplished weekly during the experimental release and sufficient risk measures have to be performed.
- Monthly inspection of the surrounding area [5 m] of the release site for transgenic pea volunteers and their manual removal and disposal.
- The release site has to be covered with a bird net immediately after sowing and until the end of the field trial. 
- In case of overlapping periods of the florescence of the transgenic pea and other pea cultivations precautions to prevent entering of the release site by pollinators during florescence have to be taken.
- After completion of the field trial an inspection of the release site and the surrounding area [5 m] for transgenic pea volunteers, their documentation and manual removal and disposal has to be accomplished monthly. The first inspection has to be accomplished in the same year as the last field trial. Inspections have to be conducted for at least one year but the inspection period is extended for another year if volunteers were observed.
- After completion of the field trial, the soil at the release site has to be shallowly dug under.
EN
To comply with requirements of Directive 2001/18/EC, Gentechnikgesetz (German Gene Technology Act): reduce possibility of GMO spread/establishment.
EN
LMO identification & risk assessment
  • BCH-LMO-SCBD-103028-2 Living Modified Organism Garden Pea modified for the expression of a single chain antibody (scFv) in the seed
    Novoplant GmbH | Production of medical or pharmaceutical compounds (human or animal) (Antibodies and antigens)
  • BCH-RA-DE-103046-4 Risk Assessment generated by a regulatory process 6786-01-0182 (adv. 42010.0182); Summary of the risk assessment of a deliberate release (field trial) of genetically modified pea (Pisum sativum; cultivar: Eiffel) BA11-2, issued by the German Competent Authority
    Garden Pea modified for the expression of a single chain antibody (scFv) in the seed | Garden pea, PEA, Production of medical or pharmaceutical compounds (human or animal)
Document on the decision, communication, notification or declaration
Additional Information
type of decision: field trial
LMO: pea (Pisum sativum) Ba11-2
legal basis: Directive 2001/18/EC, Gentechnikgesetz (German Gene Technology Act)
scope: test of field performance of LMO
authorization valid within the vegetation periode of the year 2007
locations: One experimental field; for details see German LMO/GMO location register (https://apps2.bvl.bund.de/stareg_web/localeSwitch.do?language=en&page=/showflaechen.do?)
size: 100 m² with max. 600 transgenic pea plants

- There is a Summary Notification Information Format available on the Internet (WebSNIF) for B/DE/06/182
EN