CHAPTER 2

ASSESSMENT

Conclusion by the assessing competent authority
Article 13
1
Within 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 Agency referred to in Article 37A(4) of Regulation (EC) No 1272/2008, if any adopted, whichever occurs later, the assessing 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 Agency on whether the active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.The 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 and the other competent authorities.
...
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 assessing competent authority shall make its conclusion available to the public, excluding any information in respect of which confidentiality has been granted by the assessing competent authority, unless there is an overriding public interest in its disclosure.
3
Where the assessing competent authority considers that additional information from the applicant is necessary, it shall ... set a period not exceeding 90 days for the applicant to supply such information to the other competent authorities and the assessing competent authority. The assessing competent authority shall, within 60 days from the date of receipt of the additional information evaluate the information received ....
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.
3a
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
assessing competent authority
is not yet adopted by that date, where the information available in the dossier is not sufficient for the
assessing competent authority
to conclude the assessment on whether these approval criteria are met, the
assessing competent authority
shall, in consultation with the
other competent authorities
, request from the applicant the additional information to be submitted to the
assessing competent authority and the other competent authorities
in the form of an updated supplementary dossier including the additional information. The
assessing competent authority
shall, in consultation with
... 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
assessing 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
assessing 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
assessing competent authority
, the applicant may submit to the
assessing 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
assessing competent authority
shall, without delay, inform the applicant
and 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
assessing competent authority
shall, within 90 days from the date of receipt of the additional information evaluate the information received and
circulate to the other competent authorities and the applicant
a revised draft renewal assessment report. The
assessing competent authority
shall conduct a consultation on the revised draft renewal assessment report with
the other competent authorities
and the applicant in accordance with Article 12. The
assessing competent authority
shall adopt the conclusion referred to in paragraph 1, within 120 days from the date of
circulation
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 assessing competent authority may ... consult a ... reference laboratory designated, pursuant to Regulation (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 ... reference laboratory, provide samples and analytical standards.
5
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.
Substituted 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).
Inserted by Commission Implementing Regulation (EU) 2018/1659 of 7 November 2018 amending Implementing Regulation (EU) No 844/2012 in view of the scientific criteria for the determination of endocrine disrupting properties introduced by Regulation (EU) 2018/605 (Text with EEA relevance).
Substituted by Commission Implementing Regulation (EU) 2018/1659 of 7 November 2018 amending Implementing Regulation (EU) No 844/2012 in view of the scientific criteria for the determination of endocrine disrupting properties introduced by Regulation (EU) 2018/605 (Text with EEA relevance).
Words 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)
Words in Art. 13(3a) substituted (31.12.2020) by The Environment (Miscellaneous Amendments and Revocations) (EU Exit) Regulations 2019 (S.I. 2019/559), regs. 1(3), 11(3)(a)(i)(aa); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 13(3a) substituted (31.12.2020) by The Environment (Miscellaneous Amendments and Revocations) (EU Exit) Regulations 2019 (S.I. 2019/559), regs. 1(3), 11(3)(a)(i)(bb); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 13(3a) substituted (31.12.2020) by The Environment (Miscellaneous Amendments and Revocations) (EU Exit) Regulations 2019 (S.I. 2019/559), regs. 1(3), 11(3)(a)(i)(cc); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 13(3a) substituted (31.12.2020) by The Environment (Miscellaneous Amendments and Revocations) (EU Exit) Regulations 2019 (S.I. 2019/559), regs. 1(3), 11(3)(a)(ii)(aa); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 13(3a) omitted (31.12.2020) by virtue of The Environment (Miscellaneous Amendments and Revocations) (EU Exit) Regulations 2019 (S.I. 2019/559), regs. 1(3), 11(3)(a)(ii)(bb); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 13(3a) substituted (31.12.2020) by The Environment (Miscellaneous Amendments and Revocations) (EU Exit) Regulations 2019 (S.I. 2019/559), regs. 1(3), 11(3)(b); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 13(3a) substituted (31.12.2020) by The Environment (Miscellaneous Amendments and Revocations) (EU Exit) Regulations 2019 (S.I. 2019/559), regs. 1(3), 11(3)(c)(i); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 13(3a) substituted (31.12.2020) by The Environment (Miscellaneous Amendments and Revocations) (EU Exit) Regulations 2019 (S.I. 2019/559), regs. 1(3), 11(3)(c)(ii)(aa); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 13(3a) substituted (31.12.2020) by The Environment (Miscellaneous Amendments and Revocations) (EU Exit) Regulations 2019 (S.I. 2019/559), regs. 1(3), 11(3)(c)(ii)(bb); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 13(3a) substituted (31.12.2020) by The Environment (Miscellaneous Amendments and Revocations) (EU Exit) Regulations 2019 (S.I. 2019/559), regs. 1(3), 11(3)(d)(i); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 13(3a) substituted (31.12.2020) by The Environment (Miscellaneous Amendments and Revocations) (EU Exit) Regulations 2019 (S.I. 2019/559), regs. 1(3), 11(3)(d)(ii); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 13(3a) substituted (31.12.2020) by The Environment (Miscellaneous Amendments and Revocations) (EU Exit) Regulations 2019 (S.I. 2019/559), regs. 1(3), 11(3)(e)(i)(aa); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 13(3a) substituted (31.12.2020) by The Environment (Miscellaneous Amendments and Revocations) (EU Exit) Regulations 2019 (S.I. 2019/559), regs. 1(3), 11(3)(e)(i)(bb); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 13(3a) substituted (31.12.2020) by The Environment (Miscellaneous Amendments and Revocations) (EU Exit) Regulations 2019 (S.I. 2019/559), regs. 1(3), 11(3)(e)(ii)(aa); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 13(3a) substituted (31.12.2020) by The Environment (Miscellaneous Amendments and Revocations) (EU Exit) Regulations 2019 (S.I. 2019/559), regs. 1(3), 11(3)(e)(ii)(bb); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 13(3a) substituted (31.12.2020) by The Environment (Miscellaneous Amendments and Revocations) (EU Exit) Regulations 2019 (S.I. 2019/559), regs. 1(3), 11(3)(e)(iii)(aa); 2020 c. 1, Sch. 5 para. 1(1)
Word in Art. 13(3a) substituted (31.12.2020) by The Environment (Miscellaneous Amendments and Revocations) (EU Exit) Regulations 2019 (S.I. 2019/559), regs. 1(3), 11(3)(e)(iii)(bb); 2020 c. 1, Sch. 5 para. 1(1)
Words 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)
Words 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)
Words 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)
Words 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)(cc); 2020 c. 1, Sch. 5 para. 1(1)
Words 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)(dd); 2020 c. 1, Sch. 5 para. 1(1)
Words 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)(ii)(aa); 2020 c. 1, Sch. 5 para. 1(1)
Words 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)(ii)(bb); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 13(4) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(13)(e)(i)(aa); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 13(4) 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)(e)(i)(bb); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 13(4) 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)(e)(i)(cc); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 13(4) 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)(e)(ii); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 13(4) substituted (31.12.2020) by The Pesticides (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1410), regs. 1(3), 3(2); 2020 c. 1, Sch. 5 para. 1(1)
Words 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))
Word 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))
Words 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))
Words 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))
Words 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))
Words 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))