Division 1.2.2.4 Genetic stability of the insert and phenotypic stability of the genetically modified plant

The applicant shall provide information:

1. (a)

   to demonstrate the genetic stability of the transgenic locus(i) and the phenotypic stability and inheritance pattern(s) of the introduced trait(s);

2. (b)

   in case of stacked transformation events, to establish that each of the transformation events stacked in the plant has the same molecular properties and characteristics as in the plants with the single transformation events.

For the purposes of that information, applicants shall provide data which demonstrate stability over multiple (normally five) generations or vegetative cycles for plant containing single transformation events. Data from the first and the last generations of vegetative cycles are sufficient. The source of the material used for the analysis shall be specified. Data shall be analysed using appropriate statistical methods.

For stacked transformation events comparisons between the original transformation events and the stacked transformation events shall be carried out using plant materials representative of those designed for commercial production. The applicant shall provide adequate justification for the plant materials used. Comparisons shall include comparisons of sequences of the inserts and the flanking regions obtained from GM plants containing single events and plants containing stacked transformation events.

To assess genetic stability of the transformation event(s), applicants shall use appropriate molecular approaches referred to in Section 1.2.2.2.