Once the recipient/ parental organism has been studied, the genetic modifications that were introduced into it must also be taken into consideration when establishing how these new traits will affect how the LMO interact with the likely potential receiving environment on a case-by-case basis.

Information on the genetic material that was introduced or modified, as well as the method used for the genetic transformation is useful in identifying novel properties of the LMO such as, what new gene products are expressed and which of the endogenous genes of the recipient or parental organism(s) may be affected by the genetic modification.

Typically the description of the genetic modification includes information on (i) the “donor organism(s)” or the source of the inserted genetic element(s); (ii) characteristics of each modified genetic element, including their intended and known biological function(s); (iii) the vector used, if applicable; and (iv) the transformation method. Below is a brief explanation on each of these points:

• Donor organism(s) – The relevant information on the donor organism(s) includes its taxonomic status, common name, origin and relevant biological characteristics.

• Modified genetic elements – The relevant information on the modified genetic elements encompasses the name, sequence, function and other characteristics of all the nucleic acid sequences that were modified in the LMO. These include not only the target gene but also, for example, all marker genes, regulatory sequences, and any non-coding DNA. If available, a history of use may be important with regards to potential toxicity or allergenicity of the gene products derived from the donor organism. If the genetic elements originate from a donor organism that is known to be a pest or pathogen it is also relevant to know if and how these elements contribute to the pest or pathogenic characteristics.

• Vector – In molecular biology, a vector is a nucleic acid molecule used as a vehicle to transfer foreign genetic material into another cell. If a vector, for example a plasmid, was used for the transformation, relevant information includes its identity, source or origin, and its host range.

• Transformation method – Specifying the method that was used in the transformation (e.g. Agrobacterium mediated, particle gun, etc.) is also relevant when describing the genetic modification. Depending on the transformation method, parts of the vector(s) may also be incorporated into the genome of the newly developed LMO.

• Characteristics of the modification – This refers to information about whether or not the inserted or modified genetic elements are present and functioning as expected in the LMO. Normally this involves confirmation that the DNA insert or modified genetic element is stable in the genome of the LMO. Information such as the insertion site in the genome of the recipient or parental organism(s), cellular location of the insert (e.g. chromosomal, extrachromosomal, or chloroplast DNA), its mode of inheritance and copy number may also be relevant.