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Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (Text with EEA relevance)
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1.Where the [F1assessing competent authority] has informed the applicant in accordance with Article 3(1) that its application has been submitted by the date provided for in the first subparagraph of Article 1(1) and that it contains all the elements provided for in Article 2, the applicant shall submit the supplementary dossiers to the [F2assessing competent authority].
[F31A.The assessing competent authority must notify the other competent authorities as soon as reasonably practicable after receipt of the supplementary dossiers under paragraph 1.
1B.A competent authority which receives a notification under paragraph 1A may request in writing from the applicant a copy of supplementary dossiers, which the applicant must provide as soon as reasonably practicable.]
2.The contents of the supplementary summary dossier and the supplementary complete dossier shall comply with Article 7.
[F43.The supplementary dossiers shall be submitted no later than 33 months before the expiry of the approval.] [F5The requirement applies to substances approved for use within Great Britain where that approval expires on or after 13 May 2026.]
4.Where there is more than one applicant requesting renewal of the approval of the same active substance, those applicants shall take all reasonable steps to submit their dossiers jointly.
Where such dossiers are not submitted jointly by all the applicants concerned, the reasons shall be set out in the dossiers.
5.When submitting the supplementary dossiers, the applicant may pursuant to Article 63 of Regulation (EC) No 1107/2009 request certain information, including certain parts of the dossier, to be kept confidential and shall physically separate that information.
Textual Amendments
F1Words in Art. 6(1) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(6)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)
F2Words in Art. 6(1) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(6)(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)
F3Art. 6(1A)(1B) inserted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(6)(b); 2020 c. 1, Sch. 5 para. 1(1)
F4Substituted by Commission Implementing Regulation (EU) 2020/103 of 17 January 2020 amending Implementing Regulation (EU) No 844/2012 as regards the harmonised classification of active substances (Text with EEA relevance).
F5Words in Art. 6(3) inserted (31.12.2020) by The Pesticides (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1376), regs. 1(2), 2(2)
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