Commission Regulation (EC) No 1490/2002Show full title

Article 10 U.K. Evaluation by the rapporteur Member State

1. The rapporteur Member State shall evaluate and report only on those active substances for which at least one dossier has been determined to be complete in accordance with Article 9. For such active substances it shall evaluate and report only on the complete dossiers and for the other dossiers it shall check the identity and impurities of the active substance. The rapporteur Member State shall take into consideration the information available on potentially dangerous effects in the other dossiers submitted by any notifier or by any third party in accordance with the provisions of Article 8. It shall send a draft report of its assessment of the dossier to the EFSA as quickly as possible, and at the latest 12 months after the dossier was determined to be complete. The draft assessment report shall be submitted in the format recommended in accordance with the procedure provided for in Article 19 of Directive 91/414/EEC.

At the same time, the rapporteur Member State shall make a recommendation to the Commission either:

• to include the active substance in Annex I to Directive 91/414/EEC, stating the conditions for inclusion, or

• not to include the active substance in Annex I to Directive 91/414/EEC, stating the reasons for the non-inclusion.

The rapporteur Member State shall in particular include in the draft assessment report a reference to each test and study report, for each point of Annex II and Annex III to Directive 91/414/EEC, relied on for the assessment. This reference shall be made in the form of a list of test and study reports including the title, the author(s), the date of the study or test report and the date of publication, the standard to which the test or study was conducted, the holder's name and, if any, the claim made by the holder or notifier for data protection. It shall also mention for the other notified sources of the active substances for which the dossier was considered not to be complete whether it can be concluded that such active substances are comparable within the meaning of Article 13(5) of Directive 91/414/EEC.

2. Without prejudice to Article 7 of Directive 91/414/EEC, submission of new studies shall not be accepted except for the studies as specified in Article 10(4) of Regulation (EC) No 451/2000. The rapporteur Member State may however request the notifiers to submit further data which are necessary to clarify the dossier. When doing so the rapporteur Member State shall set a time limit within which the information should be provided; this time limit shall not affect the time limit for the submission of the report referred to in paragraph 1.

The rapporteur Member State may, from the start of its examination of the dossier, consult with experts from the EFSA and may request additional technical or scientific information from other Member States to assist the evaluation. The rapporteur Member State may perform the evaluation together with a co-rapporteur Member State.

The rapporteur Member State shall request the notifiers to submit an updated summary dossier to the EFSA, the other Member States and on request to the Commission at the same time as the rapporteur's draft assessment report is sent to the EFSA.

The Member States, the Commission or the EFSA may request through the rapporteur Member State that notifiers also send them an updated complete dossier or parts thereof.

3. As soon as it becomes evident to a rapporteur Member State that it will be unable to comply with the time limit specified in paragraph 1 for the submission of the draft assessment report to the EFSA, it shall inform the Commission and the EFSA and give the reasons for the delay. Where necessary, certain active substances may be reassigned to another Member State in accordance with the procedure provided for in Article 19 of Directive 91/414/EEC.