Division I INTRODUCTION AND GENERAL PROVISIONSX1

This Annex lays down general principles for preparing dossiers to propose and justify:

• F1...

• F2the identification of CMRs, PBTs, vPvBs, or a substance of equivalent concern in accordance with Article 59,

• restrictions of the manufacture, placing on the market or use of a substance F3... .

The relevant parts of Annex I shall be used for the methodology and format of any dossier according to this Annex.

For all dossiers any relevant information from registration dossiers shall be considered and other available information may be used. For hazard information which has not been previously submitted to the Agency, a robust study summary shall be included in the dossier.