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Country's Decision or any other Communication
Record information and status
Record ID
103047
Status
Published
Date of creation
2012-01-25 09:46 UTC (german_bch@bvl.bund.de)
Date of last update
2017-05-23 14:23 UTC (german_bch@bvl.bund.de)
Date of publication
2017-07-13 15:41 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
6786-01-0182 (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
Date of the decision
2006-09-25
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
Novoplant GmbH
Novoplant GmbH
Am Schwabeplan 1B
Gatersleben
Germany, 06466
Phone:+ 49 39482 7998-0
Fax:+ 49 39482 7998-80
Email:contact@novoplant.de
Result of the decision
  • Approval of the import/use of the LMO(s) with conditions
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.
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
Garden Pea modified for the expression of a single chain antibody (scFv) in the seed
Novoplant GmbH immunodetection and purification Production of medical or pharmaceutical compounds (human or animal) - Antibodies and antigens
Show detection method(s)
Risk assessment
6786-01-0182; 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
Novoplant GmbH

immunodetection and purification
Production of medical or pharmaceutical compounds (human or animal) - Antibodies and antigens
Additional Information
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 (http://apps2.bvl.bund.de/stareg_web/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