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TITLE-II: REGISTRATION OF SUBSTANCES
CHAPTER-1: General obligation to register and information requirements
ARTICLE 12: Information to be submitted depending on tonnage
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ARTICLE 12: Information to be submitted depending on tonnage
1. The technical dossier referred to in Article 10(a) shall include under points (vi) and (vii) of that provision all physicochemical, toxicological and ecotoxicological information that is relevant and available to the registrant and as a minimum the following:
(a) the information specified in Annex VII for non-phase-in substances, and for phase-in substances meeting one or both of the criteria specified in Annex III, manufactured or imported in quantities of one tonne or more per year per manufacturer or importer;
(b) the information on physicochemical properties specified in Annex VII, section 7 for phase-in substances manufactured or imported in quantities of one tonne or more per year per manufacturer or importer which do not meet either of the criteria specified in Annex III;
(c) the information specified in Annexes VII and VIII for substances manufactured or imported in quantities of 10 tonnes or more per year per manufacturer or importer;
(d) the information specified in Annexes VII and VIII and testing proposals for the provision of the information specified in Annex IX for substances manufactured or imported in quantities of 100 tonnes or more per year per manufacturer or importer;
(e) the information specified in Annexes VII and VIII and testing proposals for the provision of the information specified in Annexes IX and X for substances manufactured or imported in quantities of 1000 tonnes or more per year per manufacturer or importer.
2. As soon as the quantity of a substance per manufacturer or importer that has already been registered reaches the next tonnage threshold, the manufacturer or importer shall inform the Agency immediately of the additional information he would require under paragraph 1. Article 26(3) and (4) shall apply adapted as necessary.
3. This Article shall apply to producers of articles adapted as necessary.
Referred by:
ARTICLE 11: Joint submission of data by multiple registrants
ARTICLE 20: Duties of the Agency
ARTICLE 22: Further duties of registrants
ARTICLE 24: Notified substances
ARTICLE 41: Compliance check of registrations
ARTICLE 77: Tasks
ARTICLE 111: Formats and software for submission of information to the Agency
ARTICLE 124: Other responsibilities
ARTICLE III: CRITERIA FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10 TONNES
ARTICLE VI: INFORMATION REQUIREMENTS REFERRED TO IN ARTICLE 10
ARTICLE VII: STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF ONE TONNE OR MORE [64]
ARTICLE VIII: STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 10 TONNES OR MORE [66]
ARTICLE IX: STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 100 TONNES OR MORE [68]
ARTICLE X: STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 1000 TONNES OR MORE [70]
ARTICLE XI: GENERAL RULES FOR ADAPTATION OF THE STANDARD TESTING REGIME SET OUT IN ANNEXES VII TO X