1.   A producer wishing to renew the inclusion in Annex I to Directive 91/414/EEC of an active substance referred to in column A of Annex I to this Regulation, or any variants thereof, shall, for each active substance separately, submit an application to the rapporteur Member State and to the co-rapporteur Member State by 28 March 2011 at the latest.

2.   When submitting an application, the applicant may, pursuant to Article 14 of Directive 91/414/EEC, request certain parts of the information to be kept confidential. It shall present such parts of the application separately, setting out the reasons for requesting confidentiality.

At the same time, the applicant shall submit any data protection claims pursuant to Article 13 of Directive 91/414/EEC.

3.   The applicant shall send a copy of the application, without the updating statement referred to in Article 5(2), to the Commission and to the Authority.

4.   Where several producers wish to renew the inclusion of the same active substance in Annex I to Directive 91/414/EEC, a joint application may be submitted by a joint representative.

5.   Where applicable, a fee, as referred to in Article 19, shall be paid upon submission of an application.

1.   An application shall be submitted in the format set out in Annex II.

2.   The application shall state which sections of the dossiers submitted for the first inclusion of the active substance require updating with new information.

Hereinafter, that part of the application is referred to as ‘the updating statement’.

3.   The updating statement shall list the new information the applicant intends to submit and demonstrate that such information is necessary, because of data requirements or criteria which were not applicable at the time of the first inclusion of the active substance or because of changes in the representative uses or because the application is for an amended renewal.

The updating statement shall separately list new studies the applicant intends to submit on vertebrate animals.

4.   Upon request from any interested party, the rapporteur Member State shall make available the information listed by the applicant as referred to in paragraph 3.

1.   Within 1 month of receipt of the application, the rapporteur Member State shall check whether the application fulfils the requirements of Articles 4 and 5.

2.   Where the rapporteur Member State considers that the application fulfils the requirements of Articles 4 and 5, it shall, within the period of 1 month provided for in paragraph 1, inform the applicant, the Commission and the Authority of the date of receipt and that the application fulfils the requirements.

3.   Where the rapporteur Member State considers that the application does not fulfil the requirements of Articles 4 and 5, it shall, within the period of 1 month provided for in paragraph 1, inform the applicant of the date of receipt and explain which requirements have not been fulfilled. It shall at the same time set the applicant a period of 14 days to render the application compliant. That period shall extend the period of 1 month provided for in paragraph 1. Where, at the end of the period set for rendering the application compliant, the rapporteur Member States considers that the application fulfils the requirements of Articles 4 and 5, paragraph 2 shall apply.

Where, at the end of the period set for rendering the application compliant, the rapporteur Member States considers that the application still does not fulfil the requirements of Articles 4 and 5, it shall, stating its reasons, immediately so inform the applicant, the Commission and the Authority.

Upon receiving the communication from the rapporteur Member State, the Commission shall, taking into account the view of the rapporteur Member State, decide whether the application fulfils the requirements of Articles 4 and 5 and inform the rapporteur Member State, the other Member States and the Authority of its decision. The rapporteur Member State shall immediately inform the applicant of that decision.

4.   Where for an active substance no application fulfils the requirements of Articles 4 and 5, in accordance with Directive 91/414/EEC, the active substance shall be removed from Annex I to that Directive. Its non-inclusion and the withdrawal of the authorisations of plant-protection products containing that active substance shall be provided for.

5.   Where two or more applications for the same active substance have been submitted separately and each is considered to fulfil the requirements of Articles 4 and 5, the rapporteur Member State shall communicate the contact details of each applicant to the other applicants.

6.   The Commission shall publish, for each active substance, the names and the addresses of the applicants whose applications are considered to fulfil the requirements of Articles 4 and 5.

1.   Where the rapporteur Member State has informed the applicant in accordance with Article 6(2) that its application fulfils the requirements of Articles 4 and 5, the applicant shall submit to the rapporteur Member State and the co-rapporteur Member State a supplementary summary dossier and a supplementary complete dossier, hereinafter ‘the supplementary dossiers’. The supplementary dossiers shall be added to the dossiers submitted for the first inclusion, with their subsequent updates, hereinafter ‘the original dossiers’.

2.   The contents of the supplementary dossiers shall comply with Article 10.

3.   The supplementary dossiers shall be submitted by the date set out for the respective active substance in column D of Annex I.

4.   At the request of the Authority or a Member State, the applicant shall make available the original dossiers where it has access to them.

5.   Where there is more than one applicant requesting renewal of the same active substance, those applicants shall take all reasonable steps to submit their dossiers jointly. Where dossiers are not submitted jointly by all applicants concerned, the reasons shall be set out in the dossiers. For each study involving vertebrate animals, the applicants concerned shall detail the attempts made to avoid duplication of testing and justify, if applicable, the need for conducting a duplicate study.

1.   The supplementary summary dossier shall include the following:

2.   The uses referred to in point (b) of paragraph 1 shall, where appropriate, include the uses evaluated for the first inclusion. At least one plant protection product referred to in that point (b) shall contain no other active substance, where such a product exists for a representative use.

3.   The complete supplementary dossiers shall contain the full text of each test and study report referred to in points (d) and (e) of paragraph 1.

1.   Within 1 month of receipt of the supplementary dossiers, the rapporteur Member State shall check whether the supplementary dossiers have been submitted by the date set in column D of Annex I for the respective active substance and whether they contain all the elements provided for in Article 10(1) and 10(3), using the checklist referred to in Article 10(1)(i).

2.   Where the supplementary dossiers have been submitted by the applicable date and contain all the elements provided for in Article 10(1) and 10(3), the rapporteur Member State shall, within the period provided for in paragraph 1, inform the applicant, the Commission and the Authority of the date of receipt and that the dossiers are considered to be complete.

The rapporteur Member State shall then start assessing the active substance.

3.   Where the supplementary dossiers have not been submitted by the applicable date or do not contain all the elements provided for in Article 10(1) and 10(3), the rapporteur Member State shall, within the period provided for in paragraph 1, inform the applicant of the date of receipt and explain which elements are missing. It shall at the same time set the applicant a period of 14 days to render the dossier compliant. That period shall extend the period of 1 month provided for in paragraph 1.

Where, at the end of the period set for rendering the supplementary dossiers compliant, the dossiers contain all the elements provided for in Article 10(1) and 10(3), paragraph 2 shall apply.

Where, at the end of the period set for rendering the supplementary dossiers compliant, the dossiers still do not contain all the elements provided for in Article 10(1) and 10(3), the rapporteur Member State shall immediately inform the applicant, the Commission and the Authority that the application is rejected, explaining the reasons for its decision.

4.   Where for an active substance no supplementary dossiers that fulfil the requirements of Article 10(1) and 10(3) have been submitted by the applicable date, in accordance with Directive 91/414/EEC, the active substance shall be removed from Annex I to that Directive. Its non-inclusion and the withdrawal of the authorisations of plant-protection products containing that active substance shall be provided for.

1.   An applicant may withdraw its application by informing the rapporteur Member State. In that case the applicant shall at the same time inform the co-rapporteur Member State, the Commission, the Authority and any other applicants having submitted an application for the same active substance of the withdrawal.

2.   An applicant may be replaced by another producer in respect of all of its rights and obligations under this Regulation by informing the rapporteur Member State, 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 co-rapporteur Member State, the Commission, the Authority and any other applicants having submitted an application for the same active substance of the replacement.

3.   Where an applicant withdraws its application and where no other application has been submitted for the same active substance fulfilling the requirements of Articles 4, 5, 9 and 10, the active substance shall be removed from Annex I to Directive 91/414/EEC. Its non-inclusion and the withdrawal of the authorisations of plant-protection products containing that active substance shall be provided for.

4.   Paragraph 3 shall not apply where several applicants have jointly submitted their dossiers and not all of these applicants have withdrawn their application. In such a case the procedure for the renewal of the inclusion of the active substance shall continue on the basis of the submitted dossiers.

1.   Within 11 months of informing the applicant that the supplementary dossiers are considered to be complete in accordance with Article 11(2), the rapporteur Member State shall, after consulting the co-rapporteur Member State, prepare and submit to the Commission, with a copy to the Authority, a report assessing whether the active substance can be expected to continue to meet the requirements for inclusion, as provided for in Article 5(1) and (2) of Directive 91/414/EEC, hereinafter ‘the renewal assessment report’.

The renewal assessment report shall also include the following:

2.   For the assessment, the rapporteur Member State shall take into account the supplementary dossiers, any information submitted by a third party, comments on such information received from the applicant and, where appropriate, the original dossiers.

3.   Where the rapporteur Member State needs additional information, it shall set a period for the applicant to supply that information. That period shall not lead to an extension of the period of 11 months provided for in paragraph 1.

4.   The rapporteur Member State may consult the Authority and request additional technical or scientific information from other Member States. Such consultations and requests shall not lead to an extension of the period of 11 months provided for in paragraph 1.

5.   Information submitted by the applicant without having been requested, or after expiry of the period set for its submission in accordance with the first subparagraph of paragraph 3, shall not be taken into account, unless submitted in accordance with Article 7 of Directive 91/414/EEC.

6.   When submitting the renewal assessment report to the Commission, the rapporteur Member State shall request the applicant to submit the supplementary summary dossier, updated to include the additional information requested by the rapporteur Member State in accordance with paragraph 3 or submitted in accordance with Article 7 of Directive 91/414/EEC, to the Authority, the other Member States and, on request, to the Commission.

1.   After receiving the renewal assessment report, the Authority shall immediately communicate it for comments to the applicant and to the Member States. Such comments shall be communicated to the Authority within 2 months, which shall collate and forward those comments, including its own, to the Commission.

2.   Upon request from any interested party, the Authority shall make the renewal assessment report available, excluding any information for which confidential treatment has been requested and is justified pursuant to Article 14 of Directive 91/414/EEC.

3.   The Authority shall make the supplementary summary dossier available to the public, with the exception of parts of it for which confidential treatment has been requested and is justified pursuant to Article 14 of Directive 91/414/EEC.

1.   The Commission shall, without delay, examine the renewal assessment report and the comments received in accordance with Article 15(1).

2.   The Commission may consult the Authority asking it for a conclusion on the entire risk assessment or on specific points thereof. Such consultation may include a request to organise a consultation of experts. The Authority shall use the guidance documents available at the time of the entry into force of this Regulation.

The Authority shall deliver its conclusion at the latest 6 months after receipt of the request.

Where paragraph 3 applies, that period shall be extended by the periods referred to in the first and the second subparagraph of that paragraph.

3.   Where the Authority considers that additional information or data from the applicant is necessary to comply with a request made by the Commission pursuant to paragraph 2, it shall in consultation with the rapporteur Member State, set a period of maximum 1 month for the applicant to supply it. It shall at the same time inform the Commission and the Member States. The applicant shall communicate the requested information to the Authority, the rapporteur Member State and the co-rapporteur Member State.

The rapporteur Member State shall, within 2 months of receipt, evaluate the information received and send its evaluation to the Authority.

4.   Information submitted by the applicant without having been requested, or after expiry of the period set for its submission in accordance with the first subparagraph of paragraph 3, shall not be taken into account, unless submitted in accordance with Article 7 of Directive 91/414/EEC.

1.   The Commission shall draft a review report, hereinafter ‘the review report’, taking into account the renewal assessment report by the rapporteur Member State, the comments referred to in Article 15(1) and, where applicable, the conclusion of the Authority.

The applicant shall be given the possibility to submit comments on the draft review report within a period set by the Commission.

The Commission shall present to the Committee referred to in Article 19(1) of Directive 91/414/EEC the draft review report within 6 months of receipt of the comments referred to in Article 15(1) or, where the Commission has consulted it in accordance with Article 16(2), of receipt of the conclusion of the Authority.

2.   On the basis of the review report and taking into account any comments submitted by the applicant within the period set by the Commission pursuant to the second subparagraph of paragraph 1, the Commission shall submit to the Committee:

3.   The draft acts referred to in paragraph 2 shall be adopted in accordance with the procedure referred to in Article 19(2) of Directive 91/414/EEC.

1.   Member States may recover the costs associated with any work they carry out within the scope of this Regulation, by means of fees or charges.

2.   Member States shall ensure that the fees or charges referred to in paragraph 1:

The fees or charges may include a scale of fixed charges based on average costs for the work referred to in paragraph 1.