5.SECTION V: POST-MARKET MONITORING PLAN
According to Article 7(3)(g) of Regulation (EC) No 1831/2003, a proposal for post-market monitoring shall be submitted for certain categories of additives in order to trace and identify any direct or indirect, immediate, delayed or unforeseen effects resulting from the use of the additive on human or animal health or the environment, in accordance with the characteristics of the products concerned.
The design of the monitoring plan shall be detailed on a case-by-case basis and identify who (e.g. applicant, users) will carry out the various tasks that the monitoring plan requires, who is responsible for ensuring that the monitoring plan is set into place and carried out appropriately, and ensure that there is a route by which the competent control authorities. The Commission and the Authority will be informed of any observed adverse effects, without prejudice to the provisions on supervision laid down in Article 12 of Regulation (EC) No 1831/2003.
In cases where the active substance is also a recognised antibiotic and its use has been shown to select resistant bacterial strains at its feed use level, field studies to monitor for bacterial resistance to the additive shall be undertaken as part of post-market monitoring.
For coccidiostats and histomonostats, field monitoring of Eimeria spp. and Histomonas meleagridis resistance, respectively, shall be undertaken, preferably during the latter part of the period of authorisation.