Conditions for the application of accelerated procedure
Where a second, third or fourth stage substance has been the subject of a non-inclusion Decision in accordance with Article 6(1) of Directive 91/414/EEC, and a draft assessment report has been prepared, any person who had participated as notifier in the procedure leading up to that decision or any person who in agreement with the original notifier replaced him for the purposes of this Regulation, may submit an application in accordance with the accelerated procedure provided for in Articles 14 to 19 of this Regulation. Such an application must be submitted within six months from the date of publication of the non-inclusion decision as regards third and fourth stage substances, or, within six months from the date of entry into force of this Regulation as regards second stage substances.
Application
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.
Substantive and procedural requirements
1. The following substantive requirements shall apply:
(a)
the specification of the active substance is the same as was the subject of the non-inclusion Decision. It may only be changed insofar as this is necessary, in the light of the reasons which gave rise to the non-inclusion Decision, to permit inclusion of that substance in Annex I to Directive 91/414/EEC;
(b)
the supported uses are the same as those that were the subject of the non-inclusion Decision. They may only be changed insofar as this is necessary, in the light of the reasons which gave rise to the non-inclusion Decision, to permit inclusion of that substance in Annex I to Directive 91/414/EEC;
(c)
it shall be for the applicant to demonstrate that the requirements in Article 5 of Directive 91/414/EEC are fulfilled.
2. With the application the applicant shall submit the following:
(a)
the additional data necessary to address the specific issues that led to the adoption of the non-inclusion Decision concerned;
(b)
any additional data reflecting the current scientific and technical knowledge and in particular changes to scientific and technical knowledge since the submission of the data which led to the non-inclusion decision;
(c)
a supplement to the original dossier, where appropriate;
(d)
a checklist demonstrating that the dossier is complete and indicating which data are new.
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 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.
Assessment by the rapporteur Member State
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.
Access to the additional report
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.
Evaluation
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.
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 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:
(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.
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 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.
