Data sharing, notification of intended studies and pre-submission advice
Article 7
1. Applicants for the approval of the same safener or synergist shall undertake all reasonable efforts to submit a joint application, or to share relevant scientific data. 2. Following the amendment of Annex I to this Regulation, in accordance with Article 6(2), applicants for the approval of a safener or a synergist shall, without delay, in accordance with Article 32b(2) of Regulation (EC) No 178/2002 notify the Authority of the title and the scope of any study commissioned or carried out by them to support an application for the approval of a safener or a synergist, as well as the laboratory or testing facility carrying out that study, and its starting and planned completion dates. Applicants for the approval of a safener or synergist shall take, where possible, measures to minimise animal testing. As part of the notification process mentioned in the preceding subparagraph, applicants shall inform the Authority if any conducted or commissioned study incorporates the utilisation of alternative testing methods. The notification shall include details on the alternative methods employed and the rationale for their use. 3. Applicants for the approval of a safener or a synergist may, in accordance with Article 32a(1) of Regulation (EC) No 178/2002, request pre-submission advice from the Authority until the complete submission of their application. The Authority shall inform the rapporteur Member State of the request and they shall jointly provide general advice.