CHAPTER II PROCEDURE FOR APPLICATIONS FOR MRLS

SECTION 1 Submission of applications for MRLs

Article 7 Requirements relating to applications for MRLs
1. The applicant shall include in an application for an MRL the following particulars and documents:
(a) the name and address of the applicant;
(b) a presentation of the application dossier including:
(i) a summary of the application;
(ii) the main substantive arguments;
(iii) an index of the documentation;
(iv) a copy of the relevant GAP applying to the specific use of that active substance;
(c) a comprehensive overview of relevant concerns raised in the available scientific literature about the plant protection product and/or its residue;
(d) the data required under Article 8(4) of Regulation (EC) No 1107/2009 relating to data requirements for the setting of MRLs for pesticides in relation to the constituent territory to which the application relates including, where appropriate, toxicological data and data on routine analytical methods for use in control laboratories, as well as plant and animal metabolism data.
Words in Art. 7(1)(d) substituted (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 4(3)(a)(i)(aa) (with Sch. 1 para. 10) (as amended by S.I. 2020/1376, regs. 1(4), 6(9)); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 7(1)(d) inserted (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 4(3)(a)(i)(bb) (with Sch. 1 para. 10) (as amended by S.I. 2020/1376, regs. 1(4), 6(9)); 2020 c. 1, Sch. 5 para. 1(1)
However, where relevant data are already publicly available, in particular when an active substance has already been evaluated under Regulation (EC) No 1107/2009 in relation to that constituent territory or when a CXL exists and such data are submitted by the applicant, a competent authority may also use such information in evaluating an application. In such cases, the evaluation report shall include a justification for using or not using such data.
Words in Art. 7(1) substituted (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 4(3)(a)(ii)(aa) (with Sch. 1 para. 10) (as amended by S.I. 2020/1376, regs. 1(4), 6(9)); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 7(1) substituted (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 4(3)(a)(ii)(bb) (with Sch. 1 para. 10) (as amended by S.I. 2020/1376, regs. 1(4), 6(9)); 2020 c. 1, Sch. 5 para. 1(1)
2. The evaluating competent authority may, where appropriate, request the applicant to provide supplementary information in addition to information required under paragraph 1 within a time limit specified by the competent authority. In no event may this period exceed two years.
Words in Art. 7(2) substituted (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 4(3)(b) (with Sch. 1 para. 10) (as amended by S.I. 2020/1376, regs. 1(4), 6(9)); 2020 c. 1, Sch. 5 para. 1(1)