Directive 2001/18/EC of the European Parliament and of the CouncilShow full title

[F1 2. Molecular characterisation U.K.

(a)

Information relating to the genetic modification

(i)

Description of the methods used for the genetic modification.

(ii)

Nature and source of the vector used.

(iii)

Source of the nucleic acid(s) used for transformation, size, and intended function of each constituent fragment of the region intended for insertion.

(b)

Information relating to the genetically modified plant

(i)

Description of the trait(s) and characteristics which have been introduced or modified.

(ii)

Information on the sequences actually inserted or deleted:

• 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, size and function of the deleted region(s),

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

• in the case of modifications other than insertion or deletion, 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,

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

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

• all Open Reading Frames, (hereafter referred to as ‘ 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. ORF is defined as a nucleotide sequence that contains a string of codons that is uninterrupted by the presence of a stop codon in the same reading frame,

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

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

• 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.

(iii)

Information on the expression of the insert:

• method(s) used for expression analysis together with their performance characteristics,

• information on the developmental expression of the insert during the life cycle of the plant,

• parts of the plant where the insert/modified sequence is expressed,

• potential unintended expression of new ORFs identified under the seventh indent of point (ii), which raise a safety concern,

• protein expression data, including the raw data, obtained from field studies and related to the conditions in which the crop is grown.

(iv)

Genetic stability of the insert and phenotypic stability of the GMHP.

(c)

Conclusions of molecular characterisation]

Textual Amendments

F1 Substituted by Commission Directive (EU) 2018/350 of 8 March 2018 amending Directive 2001/18/EC of the European Parliament and of the Council as regards the environmental risk assessment of genetically modified organisms.