1. Article 11, Article 12(2), Articles 13 and 14, Article 15(1) and (2), and Article 16 shall apply. For that purpose:

(a) any reference to operator or aircraft operator shall be read as if it were a reference to the regulated entity;

(b) any reference to aviation activity shall be read as if it were a reference to the activity of the regulated entity.

2. At the latest 4 months before a regulated entity commences the activity covered by Annex III to Directive 2003/87/EC, it shall submit to the competent authority a monitoring plan for approval, unless the competent authority has set an alternative time limit for this submission.

The monitoring plan shall consist of a detailed, complete and transparent documentation of the monitoring methodology of a specific regulated entity and shall contain at least the elements laid down in Annex I.

Together with the monitoring plan, the regulated entity shall submit the results of a risk assessment providing evidence that the proposed control activities and procedures for control activities are commensurate with the inherent risks and control risks identified.

3. In accordance with Article 15, significant modifications to the monitoring plan of a regulated entity include: