ANNEX I

Appendix 2EXPLANATORY NOTES

B.Instructions for completing the format

The report must be completed by the consent holder pursuant to Directive 2001/18/EC or the authorisation holder pursuant to Regulation (EC) No 1829/2003.

The report must be completed according to the format, to the provisions of the consent or authorisation issued pursuant to Directive 2001/18/EC or Regulation (EC) No 1829/2003 respectively and to the relevant monitoring plan.

The reported data must be illustrated as much as possible by means of diagrams, figures and tables. Statistical data should also be provided where relevant.

The space provided after each item is not indicative of the depth of the information required for the purposes of the report. Relevant supporting documentation should be provided in the form of attachments, which should be clearly cross-referenced to the relevant sections of the report.

Where the information required by the particular consent or authorisation or monitoring plan, as appropriate, cannot be reported, a detailed justification should be given.