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Country's Decision or any other Communication (DEC)
  |  
BCH-DEC-DE-109232-3   |   PDF   |   Print   |  
published: 01 Oct 2015 last updated: 06 Aug 2020
Amendment
No
General Information
6786-01-0200 (adv. 42010.0200); Decision regarding the deliberate release (field trial) of genetically modified barley (Hordeum vulgare L.) pYW210-9-(4001-4360) and pJH271-Beta-Glu-307, issued by the German Competent Authority
EN
04 May 2009
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
- If any new information on the cultivated LMOs emerges that might bear any risk for human health, animal health or the environment the national federal authority needs to be informed.

- A sign at the release site needs to indicate that at this site a field trial with genetically barley is conducted which is not approved as food or feed and that removal of plants by unauthorised persons is not permitted. The signs need to be put up in the time from sowing to harvest.

- Fertile plant material of the LMOs or material that is intended for sowing has to be transported and stored in closed and clearly labelled repositories at any time outside the release site. The label needs to distinctively describe the LMO and it needs to be noted that these LMOs and their offspring are unfit for consumption. Especially the loss of seeds needs to be avoided when seeds or seed-bearing components of the genetically modified barley lines are transported.

- Machines that have been in contact with the LMOs have to be cleaned after use on the release site to avoid unintended spread of seeds.

- To repel small mammals the field site has to be surrounded by a fine-meshed fence. Immediately after sowing and also immediately after start of ear emergence, a bird net has to be spanned over the barley to avoid feeding by birds and carryover.

- An isolation distance of 100 m is to be respected to other barley fields. Prior and during florescence of barley potential crossbreeding partners such as H. jubatum L. (foxtail barley), H. murinum L. (mouse barleye) and its subspecie H. murinum subsp. leporinum Arcang., H. secalinum Schreb. (meadow barley) und H. marinum Huds. (sea barley), Hordelymus europaeus (wood barley), Elymus spec. (wild rye) and cereals have to be removed within a radius of 35 m from the release site.

- Inspection of the release site on unexpected biological traits of the LMO and on disturbance by wildlife has to be accomplished weekly during the experimental release and sufficient risk measures have to be performed. Furthermore, particular attention needs to be given to reciprocal effects between LMO and other organisms – especially herbivores.

- Unused harvested barley seeds have to be inactivated, e.g. by burning. On the release site, remaining plant material needs to be devitalized by a non-selective herbicide and has to be shredded and worked into the soil to allow rotting after harvest. Thereby shelter crops have to be treated the same way as the LMOs. It is possible to dipose fertile plant material of the LMOs in a combustor outside of a laboratory if complete combustion is ensured and if the material is transported to the facility as described above.

- After completion of the field trial and during the next spring a shallow soil working has to be performed on the whole release site (including the sites of shelter crops). If necessary the release site needs to be sprinkled.

- After completion of the field trial an inspection of the release site for transgenic barley volunteers, their removal before florescence and disposal has to be accomplished every two weeks for one year. The inspection period has to be extended for another year if barley volunteers were observed.

- Localisation of the release site has to be ensured during inspection time.
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-108905-1 Living Modified Organism Barley modified for increased fungal resistance
    Justus-Liebig-Universität Gießen | Resistance to diseases and pests (Fungi), Resistance to herbicides (Glufosinate), Selectable marker genes and reporter genes
  • BCH-LMO-SCBD-108902-1 Living Modified Organism Barley modified for increased (1,3-1,4)-β-glucan degradation
    Justus-Liebig-Universität Gießen | Changes in quality and/or metabolite content (Carbohydrates), Resistance to herbicides (Glufosinate)
  • BCH-RA-DE-109231-3 Risk Assessment generated by a regulatory process 6786-01-0200 (adv. 42010.0200); Summary of the risk assessment of a deliberate release (field trial) of genetically modified barley (Hordeum vulgare L.) pYW210-9-(4001-4360) and pJH271-Beta-Glu-307, issued by the German Competent Authority
    Barley modified for increased fungal resistance | Barley, HORVU, Resistance to diseases and pests, Resistance to herbicides, Selectable marker genes and reporter genes | Barley modified for increased (1,3-1,4)-β-glucan degradation | Barley, HORVU, Resistance to herbicides, Changes in quality and/or metabolite content
Document on the decision, communication, notification or declaration