Division 1.2.3 Conclusions of the molecular characterisation

The molecular characterisation shall provide data on the structure and expression of the insert(s), and on the stability of the intended trait(s). This shall also apply to situations where transformation events have been stacked by conventional breeding.

It shall be specifically indicated whether the molecular characterisation of the genetic modification(s) raises safety concerns with regard to the interruption of endogenous genes or regulatory sequences.

The molecular characterisation shall also aim to identify whether the genetic modification(s) raise(s) any issues regarding the potential for producing proteins/substances other than those intended and in particular new toxins or allergens.

The potential unintended changes identified in this Section shall be addressed in the relevant complementary part(s) of the safety assessment.