scope:

Provides guidance on the design and execution of experiments for the analysis of the functional expression of the genomic modification. It gives criteria for the setup of an experimental design and the determination of the validity of its execution. The main factors influencing the specificity, reliability, and detection limits of the analysis are given for the following categories of experiments: - analysis of the expression of a genomic modification within GMOs (or clones of) or any specified part of them, including its response to internal (developmental stage, growth, organ or tissue location) and external factors (temperature, humidity, pH, other);- establishment of identity of a desired product resulting from the expression of a genomic modification in comparison with a reference; - characterization of the novel trait(s) of a GMO.