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Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC

article  10

CELEX:  02006R1907-20250623

(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;