1. If the [F1Agency] considers that further information is required, including, if appropriate, information not required in Annexes VII to X, it shall prepare a draft decision, stating reasons, requiring the registrant(s) to submit the further information and setting a deadline for its submission. A draft decision shall be prepared within 12 months of the publication of the F2 ... rolling action plan on the Agency's website for substances to be evaluated that year. The decision shall be taken in accordance with the procedure laid down in Articles 50 and 52.
2. The registrant shall submit the information required to the Agency by the deadline set.
3. The [F3Agency] shall examine any information submitted, and shall draft any appropriate decisions in accordance with this Article, if necessary, within 12 months of the information being submitted.
4. The [F4Agency] shall finish its evaluation activities within 12 months of the start of the evaluation of the substance or within 12 months of the information being submitted under paragraph 2 F5 .... If this deadline is exceeded, the evaluation shall be deemed to be finished. ]
Textual Amendments
F1 Word in Art. 46(1) substituted (31.12.2020) by The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 1 para. 36(2)(a); 2020 c. 1, Sch. 5 para. 1(1)
F2 Word in Art. 46(1) omitted (31.12.2020) by virtue of The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 1 para. 36(2)(b); 2020 c. 1, Sch. 5 para. 1(1)
F3 Word in Art. 46(3) substituted (31.12.2020) by The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 1 para. 36(3); 2020 c. 1, Sch. 5 para. 1(1)
F4 Word in Art. 46(4) substituted (31.12.2020) by The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 1 para. 36(4)(a); 2020 c. 1, Sch. 5 para. 1(1)
F5 Words in Art. 46(4) omitted (31.12.2020) by virtue of The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 1 para. 36(4)(b); 2020 c. 1, Sch. 5 para. 1(1)
Editorial Information
X1Substituted by Corrigendum to 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 (Official Journal of the European Union L 396 of 30 December 2006).