Breeding of genetically modified animals

Due to the new animal welfare law coming into effect (July 12th 2013) there is now an obligation to obtain an authorization for the breeding of genetically modified animals, if the indivual animals might be subjected to pain and/or  suffering due to their genetic modification (Definition of criteria for assessment of severity level of genetically modified animals). The animals must be evaluated using established forms (assessment of newborn litter, assessment of weaned litter, assessment single animal).


Definition of criteria for assessment of harmful phenotype of genetically modified animals â€“ general part

assessment of newborn litter (doc)

assessment of weaned litter (doc)

assessment single animal (doc)

Final assessment (doc)

document about genetically modified animal/ Implementation guide line 2010/63/EU


The following lines have to be assessed:

  • all new generated, genetically modified lines which have been modified by embryonal manipulation (transgenesis, homologous recombination, enzyme-mediated mutation, transduction etc.), by radiation or treatment with mutagenic substances 
  • creation of new lines by cross-breeding two lines with no harmful phenotype, if the progeny is expected to show a harmful phenotype
  • breeding progeny of genetically modified lines, where a harmful phenotype is expected
  • all newly imported, genetically modified lines, which have not been thoroughly characterized
  • spontaneous mutations, that - when they occur - are bred specifically and are expected to show a harmful phenotype
  • lines, which develop tumors due to the nature of their genetic modification, have to permitted always (even in cases , where the tumors develop only at a certain point in life)

The following lines do not have to be assessed:

  • Lines, where the genetically based alteration of the phenotype occurs due to the treatment with inductors (e.g. Tamoxifen, Tetracyclin etc.) do not have a harmful phenotype until the induction. As the induction only occurs within an authorized animal project, breeding of said animals does not have to be authorized.
  • Lines, where the genetically based alteration of the phenotype is supressed by treatment with substances included in the feed or water, are also seen as having no harmful phenotype and do not have to be authorized until treatment stop within an authorized animal project.
  • The presence of reporter genes (e.g. Luciferase, LacZ) in the genome and molecules which are produced by these genes do not result in a severity level per se. The breeding of lines, which only contain reporter genes, does not have to be authorized.
  • The breeding of immuno-deficient lines does not have to be authorized, if - in the course of refinement - environmental stress is reduced by protection from pathogens due to the holding conditions. Ommission of hygienic conditions during the assessment of lines is dubious at best. Adequate hygienic conditions are a must for experimental animal keeping.
  • Wildtype-animals from common inbred or outbred lines or wildtype-animals without standardised genetic background and recombinant inbred lines or similar are no genetically modified animals.
  • Lines, which are not expected to have a harmful phenotype due to the nature of their genetic modification (e.g. Cre-Lines, Flox-Lines). 
Latest Revision: 2014-02-24
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