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TITLE-II: REGISTRATION OF SUBSTANCES
CHAPTER-1: General obligation to register and information requirements
ARTICLE 10: Information to be submitted for general registration purposes
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ARTICLE 10: Information to be submitted for general registration purposes
A registration required by Article 6 or by Article 7(1) or (5) shall include all the following information:
(a) a technical dossier including:
(i) the identity of the manufacturer(s) or importer(s) as specified in section 1 of Annex VI;
(ii) the identity of the substance as specified in section 2 of Annex VI;
(iii) information on the manufacture and use(s) of the substance as specified in section 3 of Annex VI; this information shall represent all the registrant's identified use(s). This information may include, if the registrant deems appropriate, the relevant use and exposure categories;
(iv) the classification and labelling of the substance as specified in section 4 of Annex VI;
(v) guidance on safe use of the substance as specified in Section 5 of Annex VI;
(vi) study summaries of the information derived from the application of Annexes VII to XI;
(vii) robust study summaries of the information derived from the application of Annexes VII to XI, if required under Annex I;
(viii) an indication as to which of the information submitted under (iii), (iv), (vi), (vii) or subparagraph (b) has been reviewed by an assessor chosen by the manufacturer or importer and having appropriate experience;
(ix) proposals for testing where listed in Annexes IX and X;
(x) for substances in quantities of 1 to 10 tonnes, exposure information as specified in section 6 of Annex VI;
(xi) a request as to which of the information in Article 119(2) the manufacturer or importer considers should not be made available on the Internet in accordance with Article 77(2)(e), including a justification as to why publication could be harmful for his or any other concerned party's commercial interests.
Except in cases covered under Article 25(3), Article 27(6) or Article 30(3), the registrant shall be in legitimate possession of or have permission to refer to the full study report summarised under (vi) and (vii) for the purpose of registration;
(b) a chemical safety report when required under Article 14, in the format specified in Annex I. The relevant sections of this report may include, if the registrant considers appropriate, the relevant use and exposure categories.
Referred by:
ARTICLE 11: Joint submission of data by multiple registrants
ARTICLE 12: Information to be submitted depending on tonnage
ARTICLE 16: Duties of the Commission, the Agency and registrants of substances regarded as being registered
ARTICLE 17: Registration of on-site isolated intermediates
ARTICLE 18: Registration of transported isolated intermediates
ARTICLE 20: Duties of the Agency
ARTICLE 24: Notified substances
ARTICLE 27: Sharing of existing data in the case of registered substances
ARTICLE 29: Substance Information Exchange Forums
ARTICLE 41: Compliance check of registrations
ARTICLE 74: Fees and charges
ARTICLE 77: Tasks
ARTICLE 111: Formats and software for submission of information to the Agency
ARTICLE 119: Electronic public access
ARTICLE VI: INFORMATION REQUIREMENTS REFERRED TO IN ARTICLE 10
ARTICLE XV: DOSSIERS