1.   An applicant wishing to secure the inclusion in Annex I to Directive 91/414/EEC of an active substance covered by Article 1 shall submit an application for that active substance to a Member State (hereinafter referred to as rapporteur Member State) together with a complete dossier, including a summary dossier, as provided for in Article 4 demonstrating that the active substance fulfils the requirements provided for in Article 5 of that Directive. It shall be for the applicant to demonstrate that these requirements are fulfilled.

2.   When submitting his application, the applicant may, pursuant to Article 14 of Directive 91/414/EEC, request certain parts of the dossiers referred to in paragraph 1 of this Article to be kept confidential. The applicant shall explain for each document or each part of a document why it is to be considered as confidential.

The applicant shall at the same time submit any claims for data protection pursant to Article 13 of Directive 91/414/EEC.

The applicant shall submit separately the information to be kept confidential.

1.   The summary dossier shall include the following:

2.   The complete dossier shall contain the full text of the individual test and study reports concerning all the information referred to in points (b) and (c) of paragraph 1.

1.   Within 30 days of receiving the application, the rapporteur Member State shall check whether the dossiers submitted with the application contain all the elements provided for in Article 4, using the checklist referred to in Article 4(1)(d).

2.   Where one or more of the elements provided for in Article 4 are missing, the Member State shall inform the applicant, setting a time period for their submission; such time period shall be no more than six months.

3.   Where at the end of the period, referred to in paragraph 2, the applicant has not submitted the missing elements, the rapporteur Member State shall inform the applicant, the Commission and the other Member States. If, after giving the applicant an opportunity to comment, the Commission determines that the applicant has failed to submit the missing elements, it shall adopt a decision providing that the active substance concerned is not to be included in Annex I to Directive 91/414/EEC. Such a decision shall end the assessment of that active substance under this Regulation.

4.   A new application for the same substance may be submitted at any time.

5.   Where the dossiers submitted with the application contain all the elements provided for in Article 3, the rapporteur Member State shall notify the applicant, the Commission, the other Member States and the Authority of the completeness of the application.

1.   Any person or Member State wishing to submit to the rapporteur Member State information which might contribute to the assessment, in particular with regard to the potentially dangerous effects of the active substance or its residues on human and animal health and on the environment shall do so, without prejudice to Article 7 of Directive 91/414/EEC, no later than 90 days after the information referred to in Article 6 is made public.

2.   The rapporteur Member State shall submit without delay any information received to the Authority and the applicant.

3.   The applicant may send its comments on the submitted information to the rapporteur Member State and to the Authority at the latest 60 days after receiving it.

1.   Within twelve months of the date of the application provided for in Article 3(1), the rapporteur Member State shall prepare and submit to the Commission with a copy to the Authority a report (hereinafter draft assessment report) assessing whether the active substance can be expected to meet the requirements of Article 5 of Directive 91/414/EEC. It shall at the same time inform the applicant that the draft assessment report has been submitted and request him to forward the updated dossier to the Authority, the Member States and the Commission immediately.

2.   The rapporteur Member State may consult the Authority.

3.   Where the rapporteur Member State needs additional information, it shall set a time period for the applicant to supply it. In that case, the twelve-month period shall be extended by the additional time period granted by the rapporteur Member State. The additional time period shall be no more than six months and shall cease at the moment when the additional information is received by the rapporteur Member State. It shall inform the Commission and the Authority. In its assessment the rapporteur Member State shall only take into account information submitted within the time period granted.

4.   Where at the end of the period referred to in paragraph 3, the applicant has not submitted the missing elements, the rapporteur Member State shall inform the applicant, the Commission and the other Member States. If, after giving the applicant an opportunity to comment, the Commission determines that the applicant has failed to submit missing elements which are necessary to decide on whether the substance meets the requirements of Article 5 of Directive 91/414/EEC, it shall adopt a decision providing that the active substance in question is not to be included in Annex I to that Directive and ending the assessment of that active substance under this Regulation.

5.   A new application for the same substance may be submitted at any time.

1.   The Authority shall adopt a conclusion on whether the active substance can be expected to meet the requirements of Article 5 of Directive 91/414/EEC within 90 days of the end of the period provided for in the third paragraph of Article 9 of this Regulation and communicate it to the applicant, the Member States and the Commission.

Where appropriate, the Authority shall address in its conclusion the risk mitigation options in relation to the intended uses identified in the draft assessment report.

2.   Where the Authority needs additional information, it shall, in consultation with the rapporteur Member State, set a time period of maximum 90 days for the applicant to supply it to the Authority and the rapporteur Member State. In that case, the 90-day period provided for in paragraph 1 shall be extended by the additional period granted by the Authority. It shall inform the Commission and the Member States. In its conclusion the Authority shall only take into account information submitted within the time period granted.

3.   The rapporteur Member State shall assess the additional information and submit it to the Authority without delay and at the latest within 60 days after the receipt of the additional information.

4.   The Commission and the Authority shall agree on a schedule for the delivery of the conclusions in order to facilitate the planning of the work. The Commission and the Authority shall agree on the format in which the conclusions of the Authority are submitted.

1.   Without prejudice to any proposal it may submit with a view to amending the Annex to Council Directive 79/117/EEC (7), the Commission shall, at the latest six months after receipt of the conclusion of the Authority or information that the applicant has failed to submit the missing elements to the dossier, submit to the Committee a draft review report to be finalised at its meeting.

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

2.   On the basis of the review report provided for in paragraph 1, and taking into account any comments submitted by the applicant within the deadline set by the Commission under paragraph 1, a Directive or a Decision shall be adopted in accordance with the procedure referred to in Article 19(2) of the Directive 91/414/EEC, providing that:

3.   The adoption of a decision under paragraph 2(b) shall end the assessment of that active substance under this Regulation.

1.   The application referred to in Article 13 shall be submitted to the Member State which acted as rapporteur during the assessment procedure which ended with the adoption of the non-inclusion Decision unless another Member State informs the Commission that it is willing to carry out the evaluation in agreement with the original rapporteur Member State.

2.   When submitting his application, the applicant may, pursuant to Article 14 of Directive 91/414/EEC, request certain parts of the additional data referred to in paragraph 2 of Article 15 to be kept confidential. He shall explain for each document or each part of a document why it is to be considered as confidential.

The applicant shall submit separately the information to be kept confidential.

He shall at the same time submit any claims for data protection pursuant to Article 13 of Directive 91/414/EEC.

1.   The following substantive requirements shall apply:

2.   With the application the applicant shall submit the following:

1.   Any person or Member State wishing to submit to the rapporteur Member State information which might contribute to the assessment, in particular with regard to the potentially dangerous effects of the active substance or its residues on human and animal health and on the environment shall do so, without prejudice to Article 7 of Directive 91/414/EEC, no later than 90 days after the information referred to in Article 16 is made public.

2.   The rapporteur Member State shall submit without delay any information received to the Authority and the applicant.

3.   The applicant may send its comments on the submitted information to the rapporteur Member State and to the Authority at the latest 60 days after receiving it.

1.   The data referred to in Article 15(2) shall be evaluated by the rapporteur Member State referred to in Article 14(1), unless that Member State agrees with another Member State that the latter will act as rapporteur. The applicant, the Commission, the Authority and the other Member States shall be informed of this agreement.

2.   Within six months after the submission of the application the rapporteur Member State shall forward to the Authority and the Commission an evaluation of the additional data in a report, (hereinafter additional report), which should reflect current scientific and technical knowledge, and if necessary, information from the original dossier taking into consideration the information available on potentially dangerous effects submitted by any third party and any comments received from the applicant in accordance with Article 17(3). The additional report shall assess whether the active substance can be expected to meet the requirements of Article 5 of the Directive 91/414/EEC. The Rapporteur Member state shall at the same time inform the applicant that the additional report had been submitted and that the updated dossier should immediately be forwarded to the Authority, the Member States and the Commission.

The rapporteur Member State may consult the Authority.

3.   Where the rapporteur Member State needs additional information, which shall not concern the submission of new studies, it shall set a time period for the applicant to supply it. In that case, the six months period referred to in paragraph 2 shall be extended by the additional time period granted by the rapporteur Member State. The additional time period shall be maximum 90 days and shall cease at the moment when the additional information is received by the rapporteur Member State. It shall inform the Commission and the Authority. In its assessment the rapporteur Member State shall only take into account information submitted within the time period granted.

1.   After receiving the additional report the Authority shall communicate it immediately to the other Member States and the applicant for comments. Such comments shall be sent to the Authority within 30 days of receipt of the additional report. The Authority shall collate and forward the comments to the Commission.

2.   The Authority shall make the additional report available on request or keep it available for consultation by any person, except the elements thereof which have been accepted as confidential in accordance with Article 14 of the Directive 91/414/EEC.

1.   The Commission shall evaluate the additional report and where relevant the draft assessment report, referred to in Article 13, and the recommendation by the rapporteur Member State and the comments received within 30 days of receipt of the collated comments from the Authority.

The Commission may consult the Authority. Such consultation may, if appropriate, include a request to arrange a peer review, including experts from the Member States.

2.   In cases where the Commission consults the Authority for second stage substances, the latter shall deliver its conclusion at the latest 90 days after receipt of the request by the Commission. The Authority shall deliver its conclusion report at the latest six months after the request for stage three and four substances.

For third and fourth stage substances, where the Authority needs additional information, which shall not concern the submission of new studies, it shall set a time period of maximum 90 days for the applicant to supply it to the Authority and to the rapporteur Member State. In that case, the sixth months period referred to in the previous subparagraph shall be extended by the additional period granted by the Authority.

The rapporteur Member State shall assess the additional information and submit it to the Authority without delay and at the latest within 60 days after the receipt of the additional information.

3.   The Commission and the Authority shall agree on a schedule for the delivery of the conclusions in order to facilitate the planning of the work. The Commission and the Authority shall agree on the format in which the conclusions of the Authority are submitted.

1.   Without prejudice to any proposal it may submit with a view to amending the Annex to Directive 79/117/EEC, the Commission shall, at the latest six months after receipt of the information referred to in the first subparagraph of Article 20(1), or of the conclusion of the Authority or of the information that the applicant has failed to submit the missing elements to the dossier, submit to the Committee a draft review report to be finalised at its meeting.

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

2.   On the basis of the review report provided for in paragraph 1, and taking into account of any comments submitted by the applicant within the deadline set by the Commission under paragraph 1, a Directive or a Decision shall be adopted in accordance with the procedure referred to in Article 19(2) of Directive 91/414/EEC, providing that:

1.   Member States shall establish a regime obliging the applicants to pay a fee or charge for the administrative treatment and the evaluation of additional data or the dossiers related thereto.

2.   Member States shall establish a specific fee or charge for the evaluation.

3.   For this purpose, the Member States shall: