ANNEX II
PART BCriteria establishing the safety of GMMs for human health and the environment
2.General criteria
2.1.Strain verification/authentication
Identity of the strain must be precisely established. Modification must be known and verified.
2.2.Documented and established evidence of safety
Documented evidence of the safety of the organism must be provided.
2.3.Genetic stability
Where any instability could adversely affect safety, evidence of stability is required.