Division 1.2.1.3 Source of nucleic acid(s) used for transformation, size and intended function of each constituent fragment of the region intended for insertion

The applicant shall provide information on the donor organism(s) and on the nucleic acid(s) sequence(s) intended to be inserted in order to determine whether the nature of the donor organism(s) or the nucleic acid sequence(s) may trigger any safety issue.

Information regarding the function of the nucleic acid region(s) intended for insertion shall comprise the following elements:

1. (a)

   the complete sequence of the nucleic acid(s) intended to be inserted, including information on any deliberate alteration(s) to the corresponding sequence(s) in the donor organism(s);

2. (b)

   the history of safe use of the gene product(s) arising from the regions intended for insertion;

3. (c)

   data on the possible relationship of the gene products with known toxins, anti-nutrients and allergens.

Information regarding each donor organism shall comprise:

• taxonomic classification;

• history of use regarding food and feed safety.