Paragraph 49 C. Molecular CharacterisationF1

the size and copy number of all detectable inserts, both partial and complete, and methods used for its characterisation,

the organisation and sequence of the inserted genetic material at each insertion site in a standardised electronic format,

in case of deletion, the size and function of the deleted region or regions,

the subcellular location or locations of the insert or inserts (integrated in the nucleus, chloroplasts, mitochondria, or maintained in a non-integrated form), and methods for its or their determination,

in the case of modifications other than insertion or deletion, the function of the modified genetic material before and after the modification, as well as direct changes in expression of genes as a result of the modification,

the sequence information in a standardised electronic format for both 5′ and 3′ flanking regions at each insertion site,

the bioinformatic analysis using up-to-date databases, to investigate possible interruptions of known genes,

all Open Reading Frames, (‘ORFs’) within the insert (either due to rearrangement or not) and those created as a result of the genetic modification at the junction sites with genomic DNA,

the bioinformatic analysis using up-to-date databases, to investigate possible similarities between the ORFs and known genes which may have adverse effects,

the primary structure (amino acid sequence) and, if necessary, other structures, of the newly expressed protein, and

the bioinformatic analysis using up-to-date databases, to investigate possible sequence homologies and, if necessary, structural similarities between the newly expressed protein and known proteins or peptides which may have adverse effects.