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Art. 47 Quantity-based information requirements
1 Notifiers must provide the Notification Authority with the following additional information based on the quantity placed on the market:
2 After receiving the information specified in Article 46 paragraph 1 letter b, the Notification Authority shall, in accordance with Article 31 paragraph 390, inform the notifier of the data that it already holds. 3 If the risks associated with a given substance cannot be adequately assessed, the Notification Authority shall, if so requested by an assessment authority, require the notifier to submit additional information or carry out additional tests relating to the substance or its transformation products. 4 The Notification Authority, after consulting the notifier and with the agreement of the assessment authorities, shall draw up a timetable for the performance of the additional tests. 5 If the notifier fails to submit the additional test reports by the specified deadline, the Notification Authority may arrange for the required tests to be carried out at the notifier’s expense and, if necessary, prohibit the notifier from continuing to place the substance on the market. 90 The reference was amended on 1 March 2018 pursuant to Art. 12 para. 2 of the Publications Act of 18 June 2004 (SR 170.512). |