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Commission Implementing Regulation (EU) No 844/2012Dangos y teitl llawn

Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (Text with EEA relevance)

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CHAPTER 1U.K. ADMISSIBILITY

SECTION 1 U.K. Application for renewal

Article 1U.K.Submission of the application

1.[F1An 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.

F2...

F32.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.A joint application may be submitted by an association of producers designated by the producers for the purpose of compliance with this Regulation.

Textual Amendments

Article 2U.K.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 3U.K.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 [F4assessing competent authority] shall, within one month of the date of receipt of the application, inform the applicant [F5and 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 [F6assessing competent authority] shall assess any request for confidentiality. Upon a request for access to information, the [F6assessing competent authority] shall decide what information is to be kept confidential.

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 [F7assessing 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 [F8assessing competent authority].

Where the application contains all the elements provided for in Article 2 at the expiry of that period, the [F9assessing competent authority] shall, without delay, proceed in accordance with paragraph 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 [F10assessing competent authority] shall, without delay, inform the applicant [F11and the other competent authorities] that the application is inadmissible and of the reasons why it is inadmissible.

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 [F12assessing 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 [F12assessing 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.

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 [F13to the same assessing competent authority] and each of them contains all the elements provided for in Article 2, the [F14assessing competent authority] shall communicate the contact details of each applicant to the other applicant(s).

6.The [F15assessing 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.

Textual Amendments

Article 4U.K.Contacts prior to submission of supplementary dossiers

The applicant may request a meeting with the [F16assessing 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.

Textual Amendments

Article 5U.K.Access to the application

Upon receipt of the application, as provided for in Article 3(4), the [F17assessing 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.

Textual Amendments

SECTION 2 U.K. Supplementary dossiers

Article 6U.K.Submission of supplementary dossiers

1.Where the [F18assessing 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 [F19assessing competent authority].

[F201A.The assessing competent authority must notify the other competent authorities as soon as reasonably practicable after receipt of the supplementary dossiers under paragraph 1.

1B.A competent authority which receives a notification under paragraph 1A may request in writing from the applicant a copy of supplementary dossiers, which the applicant must provide as soon as reasonably practicable.]

2.The contents of the supplementary summary dossier and the supplementary complete dossier shall comply with Article 7.

[F213.The supplementary dossiers shall be submitted no later than 33 months before the expiry of the approval.] [F22The requirement applies to substances approved for use within Great Britain where that approval expires on or after 13 May 2026.]

4.Where there is more than one applicant requesting renewal of the approval of the same active substance, those applicants shall take all reasonable steps to submit their dossiers jointly.

Where such dossiers are not submitted jointly by all the applicants concerned, the reasons shall be set out in the dossiers.

5.When submitting the supplementary dossiers, the applicant may pursuant to Article 63 of Regulation (EC) No 1107/2009 request certain information, including certain parts of the dossier, to be kept confidential and shall physically separate that information.

Textual Amendments

Article 7U.K.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 [F23crop 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 [F24concern a] crop, a justification shall be submitted;

(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 [F25legislation] setting out data requirements for active substances under Regulation (EC) No 1107/2009 [F26in 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;

(f)for each point of the data requirements for the plant protection product, as set out in [F27legislation] setting out data requirements for plant protection products under Regulation (EC) No 1107/2009 [F28in 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;

(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(1);

[F21(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(2);]

(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.

Textual Amendments

Article 8U.K.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 [F29assessing competent authority] shall, within a period of one month, inform the applicant [F30and the other competent authorities] of the date of receipt of the supplementary dossiers and of the admissibility of the application.

The [F31assessing competent authority] shall assess any requests for confidentiality. In the event of a request for access to information, the [F31assessing competent authority] shall decide what information is to be kept confidential.

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 [F32assessing 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 [F33assessing competent authority].

Where at the expiry of that period the supplementary dossiers contain all the elements provided for in Article 7, the [F34assessing competent authority] shall, without delay, proceed in accordance with paragraph 1.

3.F35...

[F36Before the end of the period stated in paragraph 1], the applicant shall forward the supplementary summary dossiers to the [F37assessing 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.

4.The [F38assessing 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.

5.At the request of [F39a 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.

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 [F40assessing competent authority] shall, without delay, inform the applicant [F41and the other competent authorities] that the application is inadmissible and of the reasons why it is inadmissible.

Textual Amendments

Article 9U.K.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 [F42assessing 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 [F43other competent authorities] and any other applicants that have submitted an application for the same active substance of the replacement.

Textual Amendments

[F44Article 10U.K.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.]

Textual Amendments

(2)

[F21Regulation (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 .).]

Textual Amendments

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