Specific conditions for submissions of dossiers for active substances listed in Part A of Annex I
Article 9
1. Where the dossier concerns an active substance listed in Part A of Annex I, in addition to the information required under Article 5 and Article 6(2), the notifier shall submit the following information concerning the active substance and the plant protection product (where applicable): (a) all available information on possible risks to human and animal health and the environment including that available from searching the literature and identifying the data bases searched and search terms used; (b) available assessment reports from any OECD country; (c) for any ongoing tests and studies not yet fully completed, information on those tests and studies and a projected date of completion. 2. The dossier shall physically contain the individual test and study reports containing all the information referred to in paragraph 1. 3. Each Member State shall specify the number of copies of the dossier to be submitted by the notifier when it is acting as a rapporteur and when it receives copies under Article 20(2). The format of the dossier shall take account of the recommendations made in accordance with the procedure referred to in Article 19 of Directive 91/414/EEC.