General Conditions for evaluations of dossiers
1. Without prejudice to Article 18 the rapporteur Member State shall evaluate all dossiers submitted to it.
2. Without prejudice to Article 7 of Directive 91/414/EEC, the rapporteur Member State shall not accept the submission of new studies during the evaluation except as provided for in Article 9 (1)(c) of this Regulation.
However, the rapporteur Member State may request the notifier to submit further data which are necessary to clarify the dossier. When doing so the rapporteur Member State shall set a time limit within which the information shall be provided. The time limit shall not affect the time limit for the submission of the draft assessment report by the rapporteur Member State to the EFSA as provided for in Article 21(1) or Article 22(1).
3. The rapporteur Member State may, from the start of the evaluation of the dossier:
(a)
consult with experts from the EFSA;
(b)
request additional technical or scientific information from other Member States to assist in the evaluation.
4. Notifiers may seek specific advice from the rapporteur Member State.
Cooperation between Member States
1. The rapporteur Member States shall cooperate in the evaluation within each group set out in Annex I and shall organise such cooperation in the most effective and efficient way.
2. The rapporteur Member State identified within each group in Annex I as the ‘lead rapporteur’ shall take a lead in organising that cooperation and in organising the provision of advice to notifiers where it concerns matters of general interest to the other Member States concerned.
Specific condition for evaluations of active substances listed in Part A of Annex I
Where possible and where it does not affect the time limit for the submission of the draft assessment report as provided for in Article 21(1), the rapporteur Member State shall evaluate further information identified under Article 9(1)(c) subsequently provided by the notifier.
Completeness check of dossiers for substances listed in Parts B to G of Annex I
1. The rapporteur Member State shall assess the checklists provided by the notifiers in accordance with Article 10(2)(c).
2. The rapporteur Member State shall at the latest three months from the date of receipt of all dossiers for an active substance report to the Commission on the completeness of the dossiers.
3. For those active substances for which one or more dossiers are considered to be complete, the rapporteur Member State shall perform the evaluation as referred to in Articles 15 and 19, unless the Commission informs the rapporteur Member State, within two months of the date of receipt of the report of the rapporteur Member State on completeness, that it does not consider the dossier to be complete.
4. For those active substances for which a rapporteur Member State or the Commission consider that no dossier is complete within the meaning of Articles 5, 6 and 10, the Commission shall, within three months from the date of the receipt of the report of the rapporteur Member State on completeness, refer such a report to the Standing Committee for the Food Chain and Animal Health.
In accordance with the procedure referred to in Article 19 of Directive 91/414/EEC it shall be decided whether a dossier is to be considered complete within the meaning of Articles 5, 6 and 10.
5. The Commission shall decide, as provided for in the fourth subparagraph of Article 8 (2) of Directive 91/414/EEC, not to include in Annex I to Directive 91/414/EEC an active substance for which no complete dossier has been submitted within the time limit provided for in Article 12 of this Regulation or the second sub-paragraph of Article 13 (2).
Specific conditions for evaluations of dossiers for substances listed in Parts B to G of Annex I
1. Where active substances listed in Part D of Annex I to this Regulation have been evaluated under Directive 98/8/EC those evaluations shall be taken into account, where relevant, for the purposes of this Regulation
2. Where active substances have been evaluated under a former stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC those evaluations shall be taken into account, where relevant, for the purposes of this Regulation.
3. The rapporteur Member State shall evaluate and report only on those active substances for which at least one dossier has been determined to be complete in accordance with Articles 5, 6, and 10. For dossiers concerning the same active substance not determined to be complete, it shall check whether the identity and impurities of the active substance in those dossiers are comparable to the identity and impurities of the active substance in the dossiers considered complete. It shall record its views on this point in the draft assessment report.
The rapporteur Member State shall take into consideration the information available on potentially dangerous effects in the other dossiers submitted by any notifier or by any third party in accordance with Article 11.
General conditions for draft Assessment Reports
1. The draft assessment report shall be submitted as far as possible in the format recommended in accordance with the procedure referred to in Article 19 of Directive 91/414/EEC.
2. The rapporteur Member State shall request the notifiers to submit an updated summary dossier to the EFSA, the other Member States and on request to the Commission at the same time as the rapporteur's draft assessment report is sent to the EFSA.
The Member States, the Commission or the EFSA may request through the rapporteur Member State that notifiers also send them an updated complete dossier or parts thereof. The notifier shall provide any such updated dossier by the date specified in the request.
Specific conditions for draft Assessment Reports and Recommendations to the Commission for active substances listed in Part A of Annex I
1. The rapporteur Member State shall send the draft assessment report to the EFSA as quickly as possible, and 12 months from the date of expiry of the time limit provided for in Article 12(a) at the latest.
2. The rapporteur Member State shall include in the draft assessment report a reference to each test or study concerning each point of Annex II (Part A or Part B as appropriate) to Directive 91/414/EEC and for each point of Annex III (Part A or Part B as appropriate) to that Directive relied on for the assessment.
That reference shall be made in the form of a list of test and study reports including the title, the author(s), the date of the study or test report and the date of publication, the standard to which the test or study was conducted, the holder’s name, and if any, the claim made by the holder or notifier for data protection.
3. At the same time as the rapporteur Member State sends its assessment report to the EFSA as provided for in paragraph 1, it shall make a recommendation to the Commission:
(a)
either to include the active substance in Annex I to Directive 91/414/EEC stating where appropriate the proposed conditions for inclusion; such conditions:
(i)
may include the time limit for such inclusion:
(ii)
shall state whether any information is required, whether such additional information is included in the tests and studies referred to in Article 9(1)(c) of this Regulation and if so, the probable timetable for the provision of such information; or
(b)
not to include the active substance in Annex I to Directive 91/414/EEC, stating the proposed reasons for the non-inclusion.
4. In addition to the conditions for inclusion proposed under paragraph 2(a) of this Article, the rapporteur Member State may indicate if it has identified, for the proposed limited range of representative uses mentioned in the dossier, any information missing from the dossier which may be required by Member States as confirmatory information when they come to grant authorisations under Article 4 of Directive 91/414/EEC for plant protection products containing that active substance.
Specific conditions for draft Assessment Reports and Recommendations to the Commission for active substances listed in Parts B to G of Annex I
1. The rapporteur Member State shall send a draft assessment report to the EFSA as quickly as possible, and at the latest 12 months from the date the dossier was determined to be complete in accordance with Article 18(2).
2. The rapporteur Member State shall include in the draft assessment report a reference to each test or study concerning each point of Annex II (Part A or Part B as appropriate) to Directive 91/414/EEC and for each point of Annex III (Part A or Part B as appropriate) to that Directive relied on for the assessment.
That reference shall be made in the form of a list of test and study reports including the title, the author(s), the date of the study or test report and the date of publication, the standard to which the test or study was conducted, the holder’s name and, if any, the claim made by the holder or notifier for data protection.
3. At the same time as the rapporteur Member State sends its assessment report to the EFSA as provided for in paragraph 1, it shall make a recommendation to the Commission:
(a)
either to include the active substance in Annex I to Directive 91/414/EEC, stating the reasons for the inclusion;
(b)
or not to include the active substance in Annex I to Directive 91/414/EEC, stating the reasons for the non-inclusion.
Replacement of rapporteur Member State
1. A rapporteur Member State shall inform the Commission and the EFSA as soon as it becomes clear that it will be unable to comply with the time limits set out in Articles 21(1) and 22(1) for the submission of the draft assessment report to the EFSA and give the reasons for the delay.
2. It may be decided to replace a rapporteur Member State for a particular active substance by another Member State where:
(a)
during the assessment and evaluation provided for in Articles 15, 16, 17 and 19 it becomes apparent that there is an imbalance in the responsibilities borne and the work to be done or actually done by the Member States as rapporteurs; or
(b)
it is clear that a Member State is unable to fulfil its obligations under this Regulation.
Such replacement shall be decided in accordance with the procedure referred to in Article 19 of Directive 91/414/EEC.
3. Where it has been decided to replace a rapporteur Member State the original rapporteur Member State shall immediately after such a decision has been taken inform the notifiers concerned and shall transfer to the newly designated rapporteur Member State all correspondence and information which it has received as rapporteur Member State for the active substance concerned.
The original Member State shall return to the notifier the part of the fee referred to in Article 30 which has not been used. The newly designated rapporteur Member State may require the payment of a further fee in accordance with Article 30.
Evaluation by the EFSA
1. The EFSA shall, within 30 days of the date of receipt of the draft assessment report as provided for in Article 21(1) or Article 22(1) of this Regulation, check that it clearly complies with the format recommended in accordance with the procedure referred to in Article 19 of Directive 91/414/EEC.
In exceptional cases where the draft assessment report clearly does not fulfil those requirements the Commission shall agree with the EFSA and the rapporteur Member State on a period for resubmission of an amended report which shall not exceed three months.
2. The EFSA shall circulate the draft assessment report to the other Member States and to the Commission and may organise a consultation of experts including the rapporteur Member State.
3. The EFSA may consult some or all of the notifiers of active substances referred to in Annex I on the draft assessment report or parts thereof on the relevant active substances.
4. Without prejudice to Article 7 of Directive 91/414/EEC, submission of new studies shall not be accepted by the EFSA after receipt of the draft assessment report referred to in paragraph 1 of this Article.
However, the rapporteur Member State, with the agreement of the EFSA, may request the notifiers to submit within specified time limits further data considered by the rapporteur Member State or the EFSA necessary to clarify the dossier.
5. The EFSA shall make available at specific request or keep available for consultation by any person the following:
(a)
the draft assessment report, except the elements thereof which have been accepted as confidential in accordance with Article 14 of Directive 91/414/EEC;
(b)
the list of any data required for the evaluation of the possible inclusion of the active substance in Annex I to Directive 91/414/EEC, as finalised by the EFSA.
6. The EFSA shall evaluate the draft assessment report and submit its evaluation to the Commission on whether the active substance may be expected to meet the requirements of Article 5(1) of Directive 91/414/EEC at the latest one year from the date on which it has received both the dossier from the notifier, under Article 15(3) of this Regulation, and also the draft assessment report checked for compliance in accordance with paragraph 1 of this Article.
Where appropriate, the EFSA shall give its evaluation of the available options claimed to meet the requirements of Article 5(1) of Directive 91/414/EEC and any data requirements identified.
The Commission and the EFSA shall agree on a schedule for the submission of the evaluation in order to facilitate the planning of the work. The Commission and the EFSA shall also agree on the format of the evaluation.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
