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)

THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC, and in particular Article 19 thereof,
OJ L 309, 24.11.2009, p. 1.
Whereas:
(1) Regulation (EC) No 1107/2009 provides that the approval of an active substance may be renewed upon expiry.
(2) It is appropriate to set out the provisions necessary for the implementation of the renewal procedure.
(3) In particular, periods should be set for the different steps of the renewal procedure to ensure that it functions properly.
(4) Rules should be set out as regards confidentiality and the publication of the application for renewal, the supplementary dossiers and their updates.
(5) Rules should also be set out as regards the submission of the application for renewal and its contents and format. The applicant should be obliged to justify the submission of new information and to list separately studies concerning vertebrate animals that they intend to submit.
(6) Rules should be set out as regards the checking of the application by the rapporteur Member State.
(7) In order to ensure the proper functioning of the renewal procedure, the rapporteur Member State should, at the applicant’s request, organise prior to the submission of the supplementary dossier, a meeting to discuss the application.
(8) The supplementary dossiers submitted for renewal should, in particular, include necessary new data and new risk assessments and demonstrate why such data and risk assessments are necessary.
(9) Rules should be set out as regards the establishment of the admissibility of the application by the rapporteur Member State.
(10) Where all applications submitted are inadmissible, the Commission should adopt a Regulation on the non-renewal of the active substance concerned.
(11) Rules should be set out to ensure an independent, objective and transparent assessment of the active substance.
(12) The applicant, the Member States, with the exception of the rapporteur Member State, and the public should be given the opportunity to submit comments on the draft renewal assessment report.
(13) The European Food Safety Authority should provide conclusions and organise consultations of experts, except where the Commission informs it that a conclusion is not necessary.
(14) Rules should be set out as regards the renewal report and the adoption of a regulation on the renewal of the approval of the active substance.
(15) Commission Regulation (EU) No 1141/2010 of 7 December 2010 laying down the procedure for the renewal of the inclusion of a second group of active substances in Annex I to Council Directive 91/414/EEC and establishing the list of those substances should continue to apply with respect to the renewal of the approval of the active substances listed in Annex I thereto.
OJ L 322, 8.12.2010, p. 10.
(16) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS REGULATION:

CHAPTER 1 ADMISSIBILITY

SECTION 1 Application for renewal

Article 1 Submission of the application
1. An application for the renewal of an approval of an active substance must be submitted by a producer of the active substance to a competent authority for a constituent territory in relation to which the active substance is approved (in this Regulation, the “assessing competent authority”) no later than three years before the expiry of the approval.
When submitting an application, the applicant may, pursuant to Article 63 of Regulation (EC) No 1107/2009, request certain information to be kept confidential. In that event, the applicant shall present such parts of the application physically separated, setting out the reasons for requesting confidentiality.
At the same time, the applicant shall submit any data protection claims pursuant to Article 59 of Regulation (EC) No 1107/2009.
...
Words in Art. 1(1) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), reg. 20(2)(a)(i) (as substituted by S.I. 2019/1410, regs. 1(2), 6(6)); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 1(1) omitted (31.12.2020) by virtue of The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), reg. 20(2)(a)(ii) (as substituted by S.I. 2019/1410, regs. 1(2), 6(6)); 2020 c. 1, Sch. 5 para. 1(1)
2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 1(2) 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(2)(b); 2020 c. 1, Sch. 5 para. 1(1)
3. A joint application may be submitted by an association of producers designated by the producers for the purpose of compliance with this Regulation.

Article 2 Format and contents of the application
1. The application shall be submitted in the format set out in the Annex.
2. The application shall list the new information the applicant intends to submit. It shall demonstrate that such information is necessary in accordance with the first subparagraph of Article 15(2) of Regulation (EC) No 1107/2009.
The application shall list separately any new studies involving vertebrate animals that the applicant intends to submit.

Article 3 Checking of the application
1. Where the application has been submitted by the date provided for in the first subparagraph of Article 1(1) and contains all the elements provided for in Article 2, the assessing competent authority shall, within one month of the date of receipt of the application, inform the applicant and the other competent authorities of the date of receipt of the application and the fact that it has been submitted by the date provided for in the first subparagraph of Article 1(1) and contains all the elements provided for in Article 2.
The assessing competent authority shall assess any request for confidentiality. Upon a request for access to information, the assessing competent authority shall decide what information is to be kept confidential.
Words in Art. 3(1) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(3)(a)(i)(aa); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 3(1) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(3)(a)(i)(bb); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 3(1) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(3)(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)
2. Where the application has been submitted by the date provided for in the first subparagraph of Article 1(1) but one or more elements provided for in Article 2 are missing, the assessing competent authority shall, within one month of the date of receipt of the application, inform the applicant which elements are missing and set a period of 14 days for the submission of those elements to the assessing competent authority.
Where the application contains all the elements provided for in Article 2 at the expiry of that period, the assessing competent authority shall, without delay, proceed in accordance with paragraph 1.
Words in Art. 3(2) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(3)(b)(i)(aa); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 3(2) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(3)(b)(i)(bb); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 3(2) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(3)(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)
3. Where the application has not been submitted by the date provided for in the first subparagraph of Article 1(1), or where the application still does not contain all the elements provided for in Article 2 at the expiry of the period set for the submission of the missing elements in accordance with paragraph 2, the assessing competent authority shall, without delay, inform the applicant and the other competent authorities that the application is inadmissible and of the reasons why it is inadmissible.
Words in Art. 3(3) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(3)(c)(i); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 3(3) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(3)(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)
4. Within 14 days from the date of receipt of the information that the 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 to the assessing competent authority a copy of the application, including the information about those parts of the application in respect of which confidentiality has been requested and justified by the applicant pursuant to Article 63 of Regulation (EC) No 1107/2009.
At the same time, the applicant shall forward a copy of the application to the assessing competent authority, excluding any information in respect of which confidentiality has been requested and justified by the applicant pursuant to Article 63 of Regulation (EC) No 1107/2009.
Words in Art. 3(4) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(3)(d); 2020 c. 1, Sch. 5 para. 1(1)
5. Where, by the date provided for in the first subparagraph of Article 1(1), two or more applications for the same active substance have been submitted separately to the same assessing competent authority and each of them contains all the elements provided for in Article 2, the assessing competent authority shall communicate the contact details of each applicant to the other applicant(s).
Words in Art. 3(5) inserted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(3)(e)(i); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 3(5) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(3)(e)(ii); 2020 c. 1, Sch. 5 para. 1(1)
6. The assessing competent authority shall publish, for each active substance, the names and the addresses of the applicants whose applications have been submitted by the date provided for in the first subparagraph of Article 1(1) and contain all the elements provided for in Article 2.
Words in Art. 3(6) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(3)(f); 2020 c. 1, Sch. 5 para. 1(1)

Article 4 Contacts prior to submission of supplementary dossiers
The applicant may request a meeting with the assessing competent authority to discuss the application.
If requested, such pre-submission contacts shall take place prior to the submission of supplementary dossiers, as provided for in Article 6.
Words in Art. 4 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(4); 2020 c. 1, Sch. 5 para. 1(1)

Article 5 Access to the application
Upon receipt of the application, as provided for in Article 3(4), the assessing competent authority shall make it available to the public without delay, excluding any information in respect of which confidentiality has been requested and justified by the applicant pursuant to Article 63 of Regulation (EC) No 1107/2009, unless there is an overriding public interest in its disclosure.
Words in Art. 5 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(5); 2020 c. 1, Sch. 5 para. 1(1)

SECTION 2 Supplementary dossiers

Article 6 Submission of supplementary dossiers
1. Where the assessing 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 assessing competent authority.
Words 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)
Words 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)
1A. The assessing competent authority must notify the other competent authorities as soon as reasonably practicable after receipt of the supplementary dossiers under paragraph 1.
Art. 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)
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.
3. The supplementary dossiers shall be submitted no later than 33 months before the expiry of the approval. The requirement applies to substances approved for use within Great Britain where that approval expires on or after 13 May 2026.
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).
Words 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)
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.

Article 7 Contents of supplementary dossiers
1. The supplementary summary dossier shall include the following:
(a) a copy of the application;
(b) where the applicant is joined or replaced by one or more other applicants, the name and address of that applicant or those other applicants and, if applicable, the name of the association of producers provided for in Article 1(3);
(c) information with respect to one or more representative uses on a crop grown in Great Britain of at least one plant protection product containing the active substance, demonstrating that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are fulfilled; where the information submitted does not concern a crop, a justification shall be submitted;
Words in Art. 7(1)(c) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(7)(a)(i) (as amended by S.I. 2020/1376, regs. 1(4), 3(16)(a)); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 7(1)(c) substituted (31.12.2020) by virtue of The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(7)(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)
(d) data and risk assessments which were not part of the approval dossier or subsequent renewal dossiers and which are necessary:
(i) to reflect changes in legal requirements which have occurred since the approval or last renewal of the approval of the active substance concerned;
(ii) to reflect changes in scientific and technical knowledge since the approval or last renewal of the approval of the active substance concerned;
(iii) to reflect changes to representative uses; or
(iv) because the application is for an amended renewal;
(e) for each point of the data requirements for the active substance, as set out in legislation setting out data requirements for active substances under Regulation (EC) No 1107/2009 in relation to each constituent territory to which the application for renewal relates, for which new data are necessary in accordance with point (d), the summaries and results of tests and studies, the name of their owner and of the person or institute that has carried them out and the reason why each test or study is necessary;
Word in Art. 7(1)(e) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(7)(b)(i); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 7(1)(e) inserted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(7)(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)
(f) for each point of the data requirements for the plant protection product, as set out in legislation setting out data requirements for plant protection products under Regulation (EC) No 1107/2009 in relation to each constituent territory to which the application for renewal relates, for which new data are necessary in accordance with point (d), the summaries and results of tests and studies, the name of their owner and of the person or institute that has carried out the tests and studies, for one or more plant protection products which are representative of the supported uses, and the reason why each test or study is necessary;
Word in Art. 7(1)(f) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(7)(b)(i); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 7(1)(f) inserted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(7)(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)
(g) where relevant, documented evidence as referred to in Article 4(7) of Regulation (EC) No 1107/2009;
(h) for each test or study involving vertebrate animals, a description of the steps taken to avoid animal testing on vertebrate animals;
(i) where relevant, a copy of an application for maximum residue levels as referred to in Article 7 of Regulation (EC) No 396/2005 of the European Parliament and of the Council;
OJ L 70, 16.3.2005, p. 1.
(j) a proposal for classification where it is considered that the substance has to be classified or reclassified in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council;
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 ( OJ L 353, 31.12.2008, p. 1 .).
(k) an assessment of all information submitted;
(l) a checklist demonstrating that the supplementary dossier provided for in paragraph 3 is complete in view of the uses applied for and indicating which data are new;
(m) the summaries and results of scientific peer-reviewed open literature, as referred in Article 8(5) of Regulation (EC) No 1107/2009.
2. The uses referred to in paragraph 1(c) shall, where appropriate, include the uses evaluated for the approval or subsequent renewals. At least one plant protection product referred to in paragraph 1(c) shall contain no other active substance, where such a product exists for a representative use.
3. The supplementary complete dossier shall contain the full text of each test and study report referred to in paragraph 1(e), (f) and (m).
It shall not contain any reports of tests or studies involving the deliberate administration of the active substance or the plant protection product containing it to humans.

Article 8 Admissibility of the application
1. Where the supplementary dossiers have been submitted by the date provided for in Article 6(3) and contain all the elements provided for in Article 7, the assessing competent authority shall, within a period of one month, inform the applicant and the other competent authorities of the date of receipt of the supplementary dossiers and of the admissibility of the application.
The assessing competent authority shall assess any requests for confidentiality. In the event of a request for access to information, the assessing competent authority shall decide what information is to be kept confidential.
Words in Art. 8(1) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(8)(a)(i)(aa); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 8(1) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(8)(a)(i)(bb); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 8(1) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(8)(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)
2. Where the supplementary dossiers have been submitted by the date provided for in Article 6(3), but one or more elements provided for in Article 7 are missing, the assessing competent authority shall, within a period of one month from the date of receipt of the supplementary dossiers, inform the applicant which elements are missing and set a period of 14 days for the submission of those elements to the assessing competent authority.
Where at the expiry of that period the supplementary dossiers contain all the elements provided for in Article 7, the assessing competent authority shall, without delay, proceed in accordance with paragraph 1.
Words in Art. 8(2) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(8)(b)(i)(aa); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 8(2) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(8)(b)(i)(bb); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 8(2) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(8)(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)
3. ...
Before the end of the period stated in paragraph 1, the applicant shall forward the supplementary summary dossiers to the assessing competent authority, excluding any information in respect of which confidentiality has been requested and justified by the applicant pursuant to Article 63 of Regulation (EC) No 1107/2009.
Words in Art. 8(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(8)(c)(i); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 8(3) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(8)(c)(ii)(aa); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 8(3) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(8)(c)(ii)(bb); 2020 c. 1, Sch. 5 para. 1(1)
4. The assessing competent authority shall make the supplementary summary dossier available to the public, without delay, excluding any information in respect of which confidentiality has been requested and justified by the applicant pursuant to Article 63 of Regulation (EC) No 1107/2009, unless there is an overriding public interest in its disclosure.
Words in Art. 8(4) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(8)(d); 2020 c. 1, Sch. 5 para. 1(1)
5. At the request of a competent authority, the applicant shall make available the dossiers submitted for the approval and subsequent renewals of the approval, where it has access to them.
Words in Art. 8(5) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(8)(e); 2020 c. 1, Sch. 5 para. 1(1)
6. Where the supplementary dossiers have not been submitted by the date referred to in Article 6(3), or where at the end of the period set for the submission of the missing elements in accordance with paragraph 2 of this Article the supplementary dossiers still do not contain all the elements provided for in Article 7, the assessing competent authority shall, without delay, inform the applicant and the other competent authorities that the application is inadmissible and of the reasons why it is inadmissible.
Words in Art. 8(6) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(8)(f)(i); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 8(6) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(8)(f)(ii); 2020 c. 1, Sch. 5 para. 1(1)

Article 9 Replacement of the applicant
An applicant may be replaced by another producer in respect of all of its rights and obligations under this Regulation by informing the assessing competent authority, through a joint declaration by the applicant and the other producer. In that case, the applicant and the other producer shall, at the same time, inform the other competent authorities and any other applicants that have submitted an application for the same active substance of the replacement.
Words in Art. 9 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(9)(a); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 9 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(9)(b); 2020 c. 1, Sch. 5 para. 1(1)

Article 10 Refusal of renewal where applications are inadmissible
Where all of the applications submitted for renewal of the approval of an active substance in relation to a constituent territory are inadmissible in accordance with Article 3(3) or 8(6), the competent authority for that constituent territory must refuse to renew approval of the active substance in accordance with Article 20(1)(b) of Regulation (EC) No 1107/2009 of the European Parliament and of the Council.
Art. 10 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(10); 2020 c. 1, Sch. 5 para. 1(1)

CHAPTER 2 ASSESSMENT

Article 11 Assessment by the assessing competent authority
1. Where the application is admissible in accordance with Article 8(1), the assessing competent authority must, at the latest 13 months after the date referred to in Article 6(3), prepare and submit to the other competent authorities a report assessing whether the active substance can be expected to meet the approval criteria, as provided for in Article 4 of Regulation (EC) No 1107/2009 (‘the draft renewal assessment report’).
Words in Art. 11(1) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(11)(b)(i); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 11(1) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(11)(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)
2. The draft renewal assessment report shall also include the following:
(a) a recommendation with regard to the renewal of the approval;
(b) a recommendation on whether the substance should be considered a ‘low-risk’ substance;
(c) a recommendation on whether the substance should be considered a candidate for substitution;
(d) where relevant, a proposal to set maximum residue levels;
(e) a suggestion for the classification, or its confirmation, where applicable, or reclassification of the active substance in accordance with the criteria of Regulation (EC) No 1272/2008, as specified in and consistent with the dossier to be submitted pursuant to paragraph 9;
(f) a conclusion on which of the new studies included in the supplementary dossiers are relevant for the assessment;
(g) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 11(2)(g)(h) 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(11)(c); 2020 c. 1, Sch. 5 para. 1(1)
(h) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3. The assessing competent authority shall make an independent, objective and transparent assessment in the light of current scientific and technical knowledge. It shall take into account the supplementary dossiers, and, where appropriate, the dossiers submitted for the approval and subsequent renewals of approval.
Words in Art. 11(3) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(11)(d); 2020 c. 1, Sch. 5 para. 1(1)
4. The assessing competent authority shall first establish whether the approval criteria set out in points 3.6.2, 3.6.3, 3.6.4 and 3.7 of Annex II to Regulation (EC) No 1107/2009 are satisfied.
Where those criteria are not satisfied, the draft renewal assessment report shall be limited to those parts of the assessment, unless Article 4(7) of Regulation (EC) No 1107/2009 applies.
Words in Art. 11(4) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(11)(d); 2020 c. 1, Sch. 5 para. 1(1)
5. Where the assessing competent authority requires additional information, it shall set a period for the applicant to supply that information. ... The applicant may, pursuant to Article 63 of Regulation (EC) No 1107/2009, request such information to be kept confidential.
Words in Art. 11(5) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(11)(e)(i); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 11(5) 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(11)(e)(ii); 2020 c. 1, Sch. 5 para. 1(1)
5A. The 13 month period provided for in paragraph 1 is extended by any additional period set in accordance with paragraph 5.
Art. 11(5A)(5B) inserted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(11)(f) (as amended by S.I. 2020/1376, regs. 1(4), 3(16)(b)); 2020 c. 1, Sch. 5 para. 1(1)
5B. The additional period described in paragraph 5 must be for no more than 6 months and ceases at the earlier of—
(a) the date on which the assessing competent authority receives the additional information;
(b) the expiry of the additional period.
6. The assessing competent authority may, as it considers appropriate—
(a) obtain independent scientific advice;
(b) consult with the other competent authorities.
Art. 11(6) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(11)(g); 2020 c. 1, Sch. 5 para. 1(1)
7. 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 sentence of paragraph 5, shall not be taken into account, unless it is submitted in accordance with Article 56 of Regulation (EC) No 1107/2009.
8. When submitting the draft renewal assessment report to the other competent authorities, the assessing competent authority must require the applicant to notify the other competent authorities of the existence of any updated supplementary summary dossiers. Article 15(4) of Regulation (EC) No 1107/2009 applies to a notification under this paragraph as it applies to a notification under Article 15(3) of that Regulation.
The applicant may pursuant to Article 63 of Regulation (EC) No 1107/2009 request such information to be kept confidential. Any such requests shall be addressed to the assessing competent authority.
Words in Art. 11(8) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(11)(h)(i); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 11(8) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(11)(h)(ii); 2020 c. 1, Sch. 5 para. 1(1)
9. The assessing competent authority shall at the latest at the time of submission of the draft renewal assessment report submit a proposal to the Agency pursuant to Article 37A(2)(2) of Regulation (EC) No 1272/2008 and in accordance with the Agency’s requirements to obtain an opinion on a mandatory classification and labelling of the active substance at least for the following hazard classes:
explosives,
acute toxicity,
skin corrosion/irritation,
serious eye damage/eye irritation,
respiratory or skin sensitisation,
germ cell mutagenicity,
carcinogenicity,
reproductive toxicity,
specific target organ toxicity – single exposure,
specific target organ toxicity – repeated exposure;
hazardous to the aquatic environment.
The assessing competent authority shall duly justify its view that the criteria for classification for one or more of these hazard classes are not fulfilled.
Where a proposal for classification of an active substance has already been submitted to the Agency and its assessment is ongoing, the assessing competent authority shall submit an additional proposal for classification, limited to any hazard classes listed above that are not covered by the pending proposal unless new information has become available that was not part of the pending dossier as regards the hazard classes listed above.
For the hazard classes, which are already covered by an existing opinion of the Committee for Risk Assessment of the Agency set up pursuant to Article 76(1)(c) of Regulation (EC) No 1907/2006, or by an Agency opinion, whether or not this opinion has formed the basis of a decision concerning an entry for mandatory classification and labelling of a substance in the GB mandatory classification and labelling list, it is sufficient that the rapporteur Member State duly justifies in its submission to the Agency that the existing opinion, or where it has already formed the basis of a decision concerning the inclusion in the GB mandatory classification and labelling list, the existing classification remains valid as regards the hazard classes listed in the first subparagraph. The Agency may provide its views regarding the assessing competent authority’s submission.
Inserted 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).
Words in Art. 11(9) substituted (31.12.2020) by The Pesticides (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1376), regs. 1(2), 2(3)(a)(i)(aa)
Word in Art. 11(9) substituted (31.12.2020) by The Pesticides (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1376), regs. 1(2), 2(3)(a)(i)(bb)
Word in Art. 11(9) substituted (31.12.2020) by The Pesticides (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1376), regs. 1(2), 2(3)(a)(i)(cc)
Words in Art. 11(9) substituted (31.12.2020) by The Pesticides (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1376), regs. 1(2), 2(3)(a)(i)(dd)
Words in Art. 11(9) substituted (31.12.2020) by The Pesticides (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1376), regs. 1(2), 2(3)(a)(ii)
Words in Art. 11(9) inserted (31.12.2020) by The Pesticides (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1376), regs. 1(2), 2(3)(a)(iii)(aa)
Words in Art. 11(9) substituted (31.12.2020) by The Pesticides (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1376), regs. 1(2), 2(3)(a)(iii)(bb)
Words in Art. 11(9) substituted (31.12.2020) by The Pesticides (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1376), regs. 1(2), 2(3)(a)(iii)(cc)
Words in Art. 11(9) substituted (31.12.2020) by The Pesticides (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1376), regs. 1(2), 2(3)(a)(iii)(dd)
Words in Art. 11(9) substituted (31.12.2020) by The Pesticides (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1376), regs. 1(2), 2(3)(a)(iii)(ee)
Words in Art. 11 heading substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(11)(a); 2020 c. 1, Sch. 5 para. 1(1)
Article 11a 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 not been submitted by that date, where the information available in the supplementary dossiers is not sufficient for the assessing competent authority to conclude the assessment on whether these approval criteria are met and, where applicable, whether application of Article 4(7) is justified, the assessing competent authority shall specify in the draft renewal assessment report, in a detailed way, the additional information which is necessary in order to make the assessment concerned.
Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties ( OJ L 101, 20.4.2018, p. 33 ).
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).
Words in Art. 11a substituted (31.12.2020) by The Environment (Miscellaneous Amendments and Revocations) (EU Exit) Regulations 2019 (S.I. 2019/559), regs. 1(3), 11(2); 2020 c. 1, Sch. 5 para. 1(1)
Article 11b The Agency shall endeavour to adopt the opinion on a proposal from the assessing competent authority within 13 months from the submission referred to in Article 11(9).
Word in Art. 11b substituted (31.12.2020) by The Pesticides (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1376), regs. 1(2), 2(4)(a)
Words in Art. 11b substituted (31.12.2020) by The Pesticides (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1376), regs. 1(2), 2(4)(b)

Article 12 Comments on the draft renewal assessment report
1. The assessing competent authority shall examine whether the draft renewal assessment report ... contains all the relevant information in the agreed format and circulate it to the applicant and to the other competent authorities at the latest three months after its receipt.
Words in Art. 12(1) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(12)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 12(1) 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(12)(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 12(1) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(12)(a)(iii); 2020 c. 1, Sch. 5 para. 1(1)
2. The assessing competent authority shall make the draft renewal assessment report available to the public, after giving the applicant two weeks to request, pursuant to Article 63 of Regulation (EC) No 1107/2009, that certain parts of the draft renewal assessment report are kept confidential.
Words in Art. 12(2) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(12)(b); 2020 c. 1, Sch. 5 para. 1(1)
3. The assessing competent authority shall allow a period of 60 days from the date the report is made available to the public for the submission of written comments. Such comments shall be communicated to the assessing competent authority, which shall collate and forward those comments, including its own comments, to the other competent authorities.
Words in Art. 12(3) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(12)(c)(i); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 12(3) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(12)(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)
4. The assessing competent authority shall make the updated supplementary summary dossiers available to the public, excluding any information in respect of which confidentiality has been requested and justified by the applicant pursuant to Article 63 of Regulation (EC) No 1107/2009, unless there is an overriding public interest in its disclosure.
Words in Art. 12(4) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(12)(d); 2020 c. 1, Sch. 5 para. 1(1)

Article 13 Conclusion by the assessing competent authority
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.
...
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))
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.
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)
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.
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)
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.
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)
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.
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) 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(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)
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) 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)

Article 13a Fees and charges
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 13a omitted (31.12.2020) by virtue of The Pesticides (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1410), regs. 1(3), 3(3); 2020 c. 1, Sch. 5 para. 1(1)

Article 14 Renewal decision
1. Article 20 of Regulation (EC) No 1107/2009 applies.
Art. 14(1)(1za) substituted for Art. 14(1) (31.12.2020) by The Environment (Miscellaneous Amendments and Revocations) (EU Exit) Regulations 2019 (S.I. 2019/559), regs. 1(3), 11(4)(b); 2020 c. 1, Sch. 5 para. 1(1)
1za. Paragraph 1a applies in relation to an application where—}
(a) paragraph 7 of Schedule 1 to the Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 applies in relation to that application, and
(b) the European Food Safety Authority adopted a conclusion in relation to that application before 10th November 2018 in accordance with Article 13.
1a. ...
For the purposes of assessment of the approval criteria set out in points 3.6.5 and 3.8.2 of Annex 2 to Regulation (EC) No 1107/2009, the assessing competent authority may decide whether additional information is required and request the applicant to submit such information 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 out 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.
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 of the revised renewal assessment report with the other competent authorities and the applicant in accordance with Article 12.
The assessing competent authority shall adopt an addendum to 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 second subparagraph.
Where no additional information is submitted in accordance with the second, the third or the fourth 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 within 30 days from the expiry of the period referred to in the second or fourth subparagraph.
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 second or fourth subparagraph of this Article, shall not be taken into account, unless it is submitted in accordance with Article 56 of Regulation (EC) No 1107/2009.
Words in Art. 14(1a) 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(4)(c)(i); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 14(1a) substituted (31.12.2020) by The Environment (Miscellaneous Amendments and Revocations) (EU Exit) Regulations 2019 (S.I. 2019/559), regs. 1(3), 11(4)(c)(ii)(aa); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 14(1a) substituted (31.12.2020) by The Environment (Miscellaneous Amendments and Revocations) (EU Exit) Regulations 2019 (S.I. 2019/559), regs. 1(3), 11(4)(c)(ii)(bb); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 14(1a) substituted (31.12.2020) by The Environment (Miscellaneous Amendments and Revocations) (EU Exit) Regulations 2019 (S.I. 2019/559), regs. 1(3), 11(4)(c)(ii)(cc); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 14(1a) 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(4)(c)(ii)(dd); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 14(1a) substituted (31.12.2020) by The Environment (Miscellaneous Amendments and Revocations) (EU Exit) Regulations 2019 (S.I. 2019/559), regs. 1(3), 11(4)(c)(iii); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 14(1a) substituted (31.12.2020) by The Environment (Miscellaneous Amendments and Revocations) (EU Exit) Regulations 2019 (S.I. 2019/559), regs. 1(3), 11(4)(c)(iv)(aa); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 14(1a) substituted (31.12.2020) by The Environment (Miscellaneous Amendments and Revocations) (EU Exit) Regulations 2019 (S.I. 2019/559), regs. 1(3), 11(4)(c)(iv)(bb); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 14(1a) substituted (31.12.2020) by The Environment (Miscellaneous Amendments and Revocations) (EU Exit) Regulations 2019 (S.I. 2019/559), regs. 1(3), 11(4)(c)(iv)(cc); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 14(1a) substituted (31.12.2020) by The Environment (Miscellaneous Amendments and Revocations) (EU Exit) Regulations 2019 (S.I. 2019/559), regs. 1(3), 11(4)(c)(v)(aa); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 14(1a) substituted (31.12.2020) by The Environment (Miscellaneous Amendments and Revocations) (EU Exit) Regulations 2019 (S.I. 2019/559), regs. 1(3), 11(4)(c)(v)(bb); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 14(1a) substituted (31.12.2020) by The Environment (Miscellaneous Amendments and Revocations) (EU Exit) Regulations 2019 (S.I. 2019/559), regs. 1(3), 11(4)(c)(v)(cc); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 14(1a) substituted (31.12.2020) by The Environment (Miscellaneous Amendments and Revocations) (EU Exit) Regulations 2019 (S.I. 2019/559), regs. 1(3), 11(4)(c)(v)(dd); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 14(1a) substituted (31.12.2020) by The Environment (Miscellaneous Amendments and Revocations) (EU Exit) Regulations 2019 (S.I. 2019/559), regs. 1(3), 11(4)(c)(vi)(aa); 2020 c. 1, Sch. 5 para. 1(1)
Word in Art. 14(1a) substituted (31.12.2020) by The Environment (Miscellaneous Amendments and Revocations) (EU Exit) Regulations 2019 (S.I. 2019/559), regs. 1(3), 11(4)(c)(vi)(bb); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 14(1a) substituted (31.12.2020) by The Environment (Miscellaneous Amendments and Revocations) (EU Exit) Regulations 2019 (S.I. 2019/559), regs. 1(3), 11(4)(c)(vii)(aa); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 14(1a) substituted (31.12.2020) by The Environment (Miscellaneous Amendments and Revocations) (EU Exit) Regulations 2019 (S.I. 2019/559), regs. 1(3), 11(4)(c)(vii)(bb); 2020 c. 1, Sch. 5 para. 1(1)
2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 14(2) 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(4)(d); 2020 c. 1, Sch. 5 para. 1(1)
Word in Art. 14 heading substituted (31.12.2020) by The Environment (Miscellaneous Amendments and Revocations) (EU Exit) Regulations 2019 (S.I. 2019/559), regs. 1(3), 11(4)(a); 2020 c. 1, Sch. 5 para. 1(1)

CHAPTER 3 TRANSITIONAL AND FINAL PROVISIONS

Article 15 Transitional provisions
Regulation (EU) No 1141/2010 shall continue to apply with respect to the existing renewal applications within the meaning of Article 1(2) of that Regulation.
Words in Art. 15 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(15); 2020 c. 1, Sch. 5 para. 1(1)

Article 16 Entry into force and application
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 16 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(16); 2020 c. 1, Sch. 5 para. 1(1)
...
Words in Signature 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(17); 2020 c. 1, Sch. 5 para. 1(1)

ANNEX Format for applications, as provided for in Article 2(1)
The application shall be in writing, signed by the applicant, and sent to the assessing competent authority.
...

MODEL

1. Information concerning the applicant

1.1. Name and address of the applicant including the name of the natural person responsible for the application and other obligations resulting from this Regulation:
1.1.1. (a) Telephone No:
(b) E-mail address:
1.1.2. (a) Contact:
(b) Alternative contact:

2. Information to facilitate identification
2.1. Common name (proposed or ISO-accepted) specifying, where relevant, any variants thereof such as salts, esters or amines manufactured by the producer.
2.2. Chemical name (IUPAC and CAS nomenclature).
2.3. CAS, CIPAC and EC numbers (if available).
2.4. Empirical and structural formula, molecular mass.
2.5. Specification of purity of the active substance in g/kg which must be, whenever possible, identical or already accepted as equivalent to the one listed in the approvals register in relation to each constituent territory to which the application relates.
Words in Annex substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(18)(b); 2020 c. 1, Sch. 5 para. 1(1)
2.6. Classification and labelling of the active substance in accordance with the provisions of Regulation (EC) No 1272/2008 of the European Parliament and of the Council (health and environment effects).
OJ L 353, 31.12.2008, p. 1.

3. New information
3.1. List of new information intended to be submitted together with a justification showing that they are considered necessary, in accordance with Article 15(2) of Regulation (EC) No 1107/2009.
3.2. List of new studies intended to be submitted on vertebrate animals.
3.3. Timetable of any new and ongoing studies.
The applicant confirms that the above information submitted included in the application is correct.
Date and signature (of the person competent to act for the applicant referred to under point 1.1).
Words in Annex substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 20(18)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)
Words in Annex 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(18)(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)