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)

Changes over time for: Article 13

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Article 13U.K.Conclusion by the [F1assessing competent authority]

1.[F2Within five months from the expiry of the period referred to in Article 12(3), or within two weeks from the adoption of the opinion of the [F3Agency] referred to in Article [F437A(4)] of Regulation (EC) No 1272/2008, if any adopted, whichever occurs later, the [F5assessing competent authority] shall adopt a conclusion in the light of current scientific and technical knowledge using guidance documents applicable at the date of the submission of the supplementary dossiers and in the light of the opinion of the [F3Agency] on whether the active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.][F6The assessing competent authority may obtain independent scientific advice where it considers it appropriate to do so.] The Authority shall communicate its conclusion to the applicant [F7and the other competent authorities].

F8...

2.After giving the applicant two weeks to request, pursuant to Article 63 of Regulation (EC) No 1107/2009, that certain parts of the conclusion be kept confidential, the [F9assessing competent authority] shall make its conclusion available to the public, excluding any information in respect of which confidentiality has been granted by the [F9assessing competent authority], unless there is an overriding public interest in its disclosure.

3.Where the [F10assessing competent authority] considers that additional information from the applicant is necessary, it shall F11... set a period not exceeding [F1290 days] for the applicant to supply such information to the [F13other competent authorities] and the [F10assessing competent authority]. The [F14assessing competent authority] shall, within 60 days from the date of receipt of the additional information evaluate the information received F15....

Where the first subparagraph applies, the period referred to in paragraph 1 shall be extended by the periods referred to in the first subparagraph of this paragraph.

[F163a.For the purposes of assessment of the approval criteria set out in point 3.6.5 and point 3.8.2 of Annex II to Regulation (EC) No 1107/2009 as amended by Commission Regulation (EU) 2018/605, in relation to applications submitted in accordance with Article 1 before 10 November 2018, for which the draft renewal assessment report has been submitted but the conclusion by the [F17assessing competent authority] is not yet adopted by that date, where the information available in the dossier is not sufficient for the [F17assessing competent authority] to conclude the assessment on whether these approval criteria are met, the [F17assessing competent authority] shall, in consultation with the [F18other competent authorities], request from the applicant the additional information to be submitted to the [F19assessing competent authority and the other competent authorities] in the form of an updated supplementary dossier including the additional information. The [F20assessing competent authority] shall, in consultation with F21... the applicant, set a period for the submission of that information. Such period shall be at least of 3 months, shall not exceed 30 months, and shall be justified in relation to the type of information which has to be submitted.

Within this period set by the [F22assessing competent authority], the applicant may also submit where applicable, documentary evidence showing that the conditions for the application of the derogation under Article 4(7) of Regulation (EC) No 1107/2009 are met.

Where the [F23assessing competent authority] is able to conclude without requesting additional information that the scientific criteria for the determination of endocrine disrupting properties set out in point 3.6.5 and/or point 3.8.2 of Annex II to Regulation (EC) No 1107/2009 are met, it shall inform the applicant. Within 3 months after being informed by the [F24assessing competent authority], the applicant may submit to the [F25assessing competent authority and the other competent authorities], additional information to address the approval criteria set in point 3.6.5 and/or point 3.8.2 of Annex II to Regulation (EC) No 1107/2009, and/or documentary evidence showing that the conditions for the application of the derogation under Article 4(7) of that Regulation are met.

Where the first or third subparagraphs apply, the period referred to in paragraph 1 shall be extended by the period set for submission of the additional information.

Where no additional information is submitted in accordance with the first, second or third subparagraph within the period set for its submission, the [F26assessing competent authority] shall, without delay, inform the applicant [F27and the other competent authorities] and conclude the assessment based on the available information.

Where additional information is submitted in accordance with the first, second or third subparagraph within the period set for its submission, the [F28assessing competent authority] shall, within 90 days from the date of receipt of the additional information evaluate the information received and [F29circulate to the other competent authorities and the applicant] a revised draft renewal assessment report. The [F30assessing competent authority] shall conduct a consultation on the revised draft renewal assessment report with [F31the other competent authorities] and the applicant in accordance with Article 12. The [F32assessing competent authority] shall adopt the conclusion referred to in paragraph 1, within 120 days from the date of [F33circulation] of the revised draft renewal assessment report, using the guidance for identification of endocrine disruptors applicable at the date of the submission of the updated supplementary dossier referred to in the first subparagraph.]

4.The [F34assessing competent authority] may F35... consult a F36... reference laboratory designated, pursuant to [F37Regulation (EU) 2017/625 of the European Parliament and of the Council ], for the purposes of verifying whether the analytical method for the determination of the residues proposed by the applicant is satisfactory and complies with the requirements in Article 29(1)(g) of Regulation (EC) No 1107/2009. The applicant shall, if requested by the F38... reference laboratory, provide samples and analytical standards.

[F395.Information submitted by the applicant without having been requested, or provided after the expiry of the period set for its submission in accordance with the first subparagraph of paragraph 3 or in accordance with the first or third subparagraphs of paragraph 3a of this Article, shall not be taken into account, unless it is submitted in accordance with Article 56 of Regulation (EC) No 1107/2009.]

Textual Amendments

F1Words in Art. 13 heading substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(13)(a); 2020 c. 1, Sch. 5 para. 1(1)

F2Substituted 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).

F3Words in Art. 13(1) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), reg. 20(13)(b)(i)(aa) (as substituted by S.I. 2020/1376, regs. 1(4), 3(16)(c))

F4Word in Art. 13(1) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), reg. 20(13)(b)(i)(bb) (as substituted by S.I. 2020/1376, regs. 1(4), 3(16)(c))

F5Words in Art. 13(1) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), reg. 20(13)(b)(i)(cc) (as substituted by S.I. 2020/1376, regs. 1(4), 3(16)(c))

F6Words in Art. 13(1) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), reg. 20(13)(b)(i)(dd) (as substituted by S.I. 2020/1376, regs. 1(4), 3(16)(c))

F7Words in Art. 13(1) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), reg. 20(13)(b)(i)(ee) (as substituted by S.I. 2020/1376, regs. 1(4), 3(16)(c))

F8Words in Art. 13(1) omitted (31.12.2020) by virtue of The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), reg. 20(13(b)(ii) (as substituted by S.I. 2020/1376, regs. 1(4), 3(16)(c))

F9Words in Art. 13(2) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(13)(c); 2020 c. 1, Sch. 5 para. 1(1)

F10Words in Art. 13(3) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(13)(d)(i)(aa); 2020 c. 1, Sch. 5 para. 1(1)

F11Words in Art. 13(3) omitted (31.12.2020) by virtue of The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(13)(d)(i)(bb); 2020 c. 1, Sch. 5 para. 1(1)