Application
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.
Dossiers
1. The summary dossier shall include the following:
(a)
data with respect to a limited range of representative uses of at least one plant protection product containing the active substance, demonstrating that the requirements of Article 5 of Directive 91/414/EEC are met;
(b)
for each point of the data requirements for the active substance referred to in Annex II to Directive 91/414/EEC, 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;
(c)
for each point of the data requirements for the plant protection product referred to in Annex III to Directive 91/414/EEC, 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 relevant to the assessment of the requirements referred to in Article 5 of that Directive taking into account that data gaps in the Annex II or Annex III dossier, resulting from the proposed limited range of representative uses, may lead to restrictions in the Annex I inclusion;
(d)
a checklist demonstrating that the dossier provided for in paragraph 2 is complete;
(e)
the reasons why the test and study reports submitted are necessary for first inclusion of the active substance;
(f)
an assessment of all information submitted.
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.
Completeness check of the dossier
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.
Publication of information
For applications for which completeness has been established the Commission shall make public the following information:
(a)
the name of the active substance;
(b)
the date of application;
(c)
the name and address of applicants;
(d)
the rapporteur Member State.
Submission of information by third parties
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.
Assessment by the rapporteur Member State
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.
Receipt of and access to the draft assessment report
The Authority shall circulate the draft assessment report received from the rapporteur Member State to the applicant, the other Member States and the Commission after receiving the dossier provided for in Article 8(1).
It shall make it available to the public, after giving the applicant two weeks to request that certain parts of the draft assessment report be kept confidential.
The Authority shall allow a period of 90 days for the submission of written comments from Member States and the applicant.
Where appropriate, the Authority shall organise a peer review, including experts from the Member States.
Conclusion by the Authority
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.
Presentation of a draft directive or draft decision
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:
(a)
an active substance is included in Annex I to Directive 91/414/EEC subject to conditions and restrictions, where appropriate;
(b)
an active substance is not included in Annex I to that Directive.
3. The adoption of a decision under paragraph 2(b) shall end the assessment of that active substance under this Regulation.
Access to the review report
The finalised review report, excluding any parts which refer to confidential information contained in the dossiers and determined as such in accordance with Article 14 of the Directive 91/414/EEC, shall be made available for public consultation.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
