Division C Characteristics of the modified organism

Information relating to the genetic modification:

1. (a)

   methods used for the modification;

2. (b)

   methods used to construct and introduce the insert(s) into the recipient or to delete a sequence;

3. (c)

   description of the insert and/or vector construction;

4. (d)

   purity of the insert from any unknown sequence and information on the degree to which the inserted sequence is limited to the DNA required to perform the intended function;

5. (e)

   methods and criteria used for selection;

6. (f)

   sequence, functional identity and location of the altered/inserted/deleted nucleic acid segment(s) in question with particular reference to any known harmful sequence.

Information on the final GMO:

1. (a)

   description of genetic trait(s) or phenotypic characteristics and in particular any new traits and characteristics which may be expressed or no longer expressed;

2. (b)

   structure and amount of any vector and/or donor nucleic acid remaining in the final construction of the modified organism;

3. (c)

   stability of the organism in terms of genetic traits;

4. (d)

   rate and level of expression of the new genetic material. Method and sensitivity of measurement;

5. (e)

   activity of the expressed protein(s);

6. (f)

   description of identification and detection techniques including techniques for the identification and detection of the inserted sequence and vector;

7. (g)

   sensitivity, reliability (in quantitative terms) and specificity of detection and identification techniques;

8. (h)

   history of previous releases or uses of the GMO;

9. (i)

   considerations for human health and animal health, as well as plant health:

   1. (i)

      toxic or allergenic effects of the GMOs and/or their metabolic products;

   2. (ii)

      comparison of the modified organism to the donor, recipient or (where appropriate) parental organism regarding pathogenicity;

   3. (iii)

      capacity for colonisation;

   4. (iv)

      if the organism is pathogenic to humans who are immunocompetent:

      • diseases caused and mechanism of pathogenicity including invasiveness and virulence,

      • communicability,

      • infective dose,

      • host range, possibility of alteration,

      • possibility of survival outside of human host,

      • presence of vectors or means of dissemination,

      • biological stability,

      • antibiotic resistance patterns,

      • allergenicity,

      • availability of appropriate therapies;

   5. (v)

      other product hazards.