Monitoring
Article 4
1. Throughout the period of validity of the consent, the consent holder shall ensure that the monitoring plan, contained in the notification and consisting of a general surveillance plan to check for any adverse effects on human and animal health or the environment arising from handling or use of the product referred to in Article 2(1), is put in place and implemented. 2. The consent holder shall directly inform the operators and users concerning the safety and general characteristics of the product and of the conditions as to monitoring, including the appropriate management measures to be taken in case of accidental cultivation. 3. The consent holder shall submit to the Commission and to the competent authorities of the Member States annual reports on the results of all monitoring activities. The first annual report shall be submitted one year after final consent is granted. 4. Without prejudice to Article 20 of Directive 2001/18/EC, the monitoring plan as notified shall be revised by the consent holder, where appropriate and subject to the agreement of the Commission and the competent authority of the Member State which received the original notification, and/or by the competent authority of the Member State which received the original notification, subject to the agreement of the Commission, in the light of the results of the monitoring activities. Proposals for a revised monitoring plan shall be submitted to the competent authorities of the Member States. 5. The consent holder shall be in the position to give evidence to the Commission and the competent authorities of the Member States of the following: (a) that the existing monitoring networks, including national botanic survey networks and plant protection services, as specified in the monitoring plan contained in the notification gather the information relevant for the monitoring of the products; and (b) that the existing monitoring networks referred to in point (a) have agreed to make available that information to the consent holder before the date of submission of the monitoring reports to the Commission and competent authorities of the Member States in accordance with paragraph 3.