Part III CARTAGENA PROTOCOL

The application shall provide the information required under Articles 5(3)(c) and 17(3)(c) of Regulation (EC) No 1829/2003 for the purpose of complying with Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity.

The provided information shall contain as a minimum the information specified in Annex II to Regulation (EC) No 1946/2003 of the European Parliament and of the Council^f1:

1. (a)

   The name and contact details of the applicant for a decision for domestic use;

2. (b)

   The name and contact details of the authority responsible for the decision;

3. (c)

   Name and identity of the GMO;

4. (d)

   Description of the gene modification, the technique used, and the resulting characteristics of the GMO;

5. (e)

   Any unique identification of the GMO;

6. (f)

   Taxonomic status, common name, point of collection or acquisition, and characteristics of recipient organism or parental organisms related to biosafety;

7. (g)

   Centres of origin and centres of genetic diversity, if known, of the recipient organism and/or the parental organisms and a description of the habitats where the organisms may persist or proliferate;

8. (h)

   Taxonomic status, common name, point of collection or acquisition, and characteristics of the donor organism or organisms related to biosafety;

9. (i)

   Approved uses of the GMO;

10. (j)

    A risk assessment report consistent with Annex II to Directive 2001/18/EC;

11. (k)

    Suggested methods for the safe handling, storage, transport and use, including packaging, labelling, documentation, disposal and contingency procedures, where appropriate.