Commission Decision of 16 January 2006 concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a maize product (Zea mays L., hybrid MON 863 × MON 810) genetically modified for resistance to corn rootworm and certain lepidopteran pests of maize (notified under document number C(2005) 5980) (Only the German text is authentic) (2006/47/EC)

Article 4 Monitoring

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, the objective of which is to check for any adverse effects on human and animal health or the environment arising from handling or use of the product, 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 grain spillage.

3. The consent holder shall submit to the Commission and to the competent authorities of the Member States annual reports on the results of the monitoring activities.

4. Without prejudice to Article 20 of Directive 2001/18/EC the monitoring plan as notified shall, where appropriate and subject to the agreement of the Commission and the competent authority of the Member State which received the original notification, be revised by the consent holder and/or by the competent authority of the Member State which received the original notification, 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:

(a) that the monitoring networks as specified in the monitoring plan contained in the notification collect the information relevant for the monitoring of the product, and

(b) that the members of these networks have agreed to make available that information to the consent holder before the date of the submission of the monitoring reports to the Commission and competent authorities of the Member States in accordance with paragraph 3.