ÖNORM EN 12682

This European Standard 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 limits of detection for an analysis are given for the following categories of experirnents : 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. This European Standard does not cover procedures for the analysis of pleiotropic effects of a genomic modification or the act of generating the GM0 (e.g. somaclonal variation) on the phenotype of rnodified organisms, which cannot be predicted from the knowledge of the type of the genomic modification. However, the principles stated in this European Standard are applicable for the execution of any analysis of gene functions.