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REACH - Registration, Evaluation and Authorisation of Chemicals
TITLE-II: REGISTRATION OF SUBSTANCES
CHAPTER-1: General obligation to register and information requirements
ARTICLE 10: Information to be submitted for general registration purposes
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.