Belarus | BCH-DEC-BY-262014 | Country's Decision or any other Communication | Biosafety Clearing-House

Loading...
  |  
BCH-DEC-BY-262014-2   |   PDF   |   Print   |  

Country's Decision or any other Communication (DEC)

last updated: 03 Oct 2022
Amendment
No
General Information
Decision on Release of Transgenic Goats Under Special Limited Conditions
EN
28 Feb 2019
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
No
Yes
Yes
Result of the decision
Approval of the import and/or use of the LMO(s) with conditions
The Expert Council for the Safety of Genetically Engineered Organisms of the Ministry of Natural Resources concluded that transgenic goats, producers of recombinant human lactoferrin, may be allowed for passing procedure of new breed State Registration, as well as for the purpose of carrying out relevant tests and subsequent use of the target protein. A herd of transgenic goats should be kept in a controlled environment that prevents the exchange of genetic material with non-transgenic individuals.
EN
The Expert Council`s recommendations are as follows:
A herd of transgenic goats should be kept in a controlled environment that prevents the exchange of genetic material with non-transgenic individuals;
appropriate environmental monitoring by botanists and zoologists should be provided;
the final product (lactoferrin) can only be used for economic purposes;
it is necessary to screen the final product for presence of the inserted new genetic sequence.
EN
Information sharing with other databases
Yes
LMO identification & risk assessment
  • BCH-LMO-SCBD-108045-1 Living Modified Organism Domestic goat modified to produce human lactoferrin
    Republican Unitary Enterprise "Scientific and Practical Center of the National Academy of Sciences of Belarus on Animal Husbandry" | Production of medical or pharmaceutical compounds (human or animal)
  • BCH-RA-BY-113167-3 Risk Assessment generated by a regulatory process Expert conclusion based on the results of the safety assessment for human health and the environment of genetically engineered organism - Domestic goat modified to produce human lactoferrin
    Domestic goat modified to produce human lactoferrin | Domestic goat, Goat, CAPHI, Production of medical or pharmaceutical compounds (human or animal)
Document on the decision, communication, notification or declaration
Loading...