Submission of dossiers by more than one notifier
1. Where for any active substance listed in Annex I there is more than one notifier, the notifiers concerned shall take all reasonable steps to submit the dossier for such substance collectively.
Where the dossier is not submitted by all such notifiers, it shall contain details of the efforts made and the reasons why certain notifiers have not participated in the submission of the dossier.
2. Where an active substance has been notified by more than one notifier, those notifiers shall, for each study involving vertebrate animals, give details of the attempts made to avoid duplication of testing and give, if applicable, the reasons for conducting a duplicate study.
Submission of dossiers to the rapporteur Member State
1. The notifier shall submit the dossier for the active substance (the dossier) to the rapporteur Member State.
2. The dossier shall include the following:
(a)
a copy of the notification; in the case of a collective notification made by more than one producer as referred to in Article 5(1), it shall include:
(i)
a copy of the notifications made in accordance with Article 4 or 5 of Regulation (EC) No 1112/2002 or Article 4 of this Regulation;
(ii)
the name of the person designated by the producers concerned as being responsible for the collective notification who will act as a contact point during the procedure;
(b)
a limited range of representative uses of the active substance, in respect of which the data submitted by the notifier in the dossier shall demonstrate that for one or more preparations, the requirements set out in Article 5 of Directive 91/414/EEC for inclusion of the active substance in Annex I to that Directive may be met.
3. When requested by the rapporteur Member State as provided for in Article 20(2) to circulate the updated summary dossier or where relevant the updated complete dossier or parts thereof the notifier shall do this at the latest one month from the date of receipt of such a request.
Dossiers for active substances submitted under Directive 98/8/EC
By derogation from Articles 5 and 6, where an active substance has been notified under Directive 98/8/EC the notifier may submit:
(a)
a copy of the dossier submitted under Directive 98/8/EC;
(b)
any additional information referred to in Annexes II and III to Directive 91/414/EEC necessary to justify the inclusion of the active substance in Annex I to that Directive by reference to uses falling within the scope of that Directive.
Dossiers for active substances submitted under Regulation (EC) No 1490/2002
Where a dossier has been submitted under Regulation (EC) No 1490/2002, the person who submitted that dossier may submit, together with the further dossier submitted under this Regulation:
(a)
a reference to the dossier submitted under Regulation (EC) No 1490/2002;
(b)
any additional information referred to in Annexes II and III to Directive 91/414/EEC necessary to justify the inclusion of the active substance in Annex I to that Directive by reference to uses falling within the scope of this Regulation.
Specific conditions for submissions of dossiers for active substances listed in Part A of Annex I
1. Where the dossier concerns an active substance listed in Part A of Annex I, in addition to the information required under Article 5 and Article 6(2), the notifier shall submit the following information concerning the active substance and the plant protection product (where applicable):
(a)
all available information on possible risks to human and animal health and the environment including that available from searching the literature and identifying the data bases searched and search terms used;
(b)
available assessment reports from any OECD country;
(c)
for any ongoing tests and studies not yet fully completed, information on those tests and studies and a projected date of completion.
2. The dossier shall physically contain the individual test and study reports containing all the information referred to in paragraph 1.
3. Each Member State shall specify the number of copies of the dossier to be submitted by the notifier when it is acting as a rapporteur and when it receives copies under Article 20(2).
The format of the dossier shall take account of the recommendations made in accordance with the procedure referred to in Article 19 of Directive 91/414/EEC.
Specific conditions for submissions of dossiers for active substances listed in Parts B to G of Annex I
1. Where the dossier concerns an active substance listed in Part B to G of Annex I, the notifier shall submit a dossier and a summary dossier.
2. The notifier(s) shall include in the summarydossier:
(a)
the information required under Article 5 and Article 6(2) of this Regulation;
(b)
for 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, the summaries and results of tests and studies and the name of the person or institute that has carried out those tests and studies;
(c)
a checklist to be filled in by the notifier, demonstrating that the dossier is complete in accordance with Article 18 of this Regulation.
The tests and studies as referred to in paragraph 2(b) of this Article shall be those relevant to the assessment of the criteria referred to in Article 5 of Directive 91/414/EEC for one or more preparations for the uses taking into account the fact that data gaps in the dossier as regards the information required under Annex II of Directive 91/414/EEC, resulting from the proposed limited range of representative uses of the active substance, may lead to restrictions in the inclusion in Annex I of Directive 91/414/EEC.
3. The complete dossier shall physically contain the individual test and study reports concerning all the information referred to in point (b) and the second subparagraph of paragraph 2.
4. Each Member State shall specify the number of copies and the format of the summary and the complete dossiers to be submitted by the notifiers.
In defining the format of the complete and summary dossiers Member States shall take account of the recommendations made in accordance with the procedure referred to in Article 19 of Directive 91/414/EEC.
Submission of information by third parties
Any natural or legal person wishing to submit relevant information which may contribute to the evaluation of an active substance listed in Annex I, in particular with regard to the potentially dangerous effects of that substance or its residues on human and animal health and on the environment, shall do so by the relevant time limit set out in Article 12.
Such information shall be submitted to the rapporteur Member State and the EFSA. When requested by the rapporteur Member State such person shall also submit that information to the other Member States at the latest one month from the date of receipt of such a request.
Time limits for submission of dossiers
The notifier(s) shall submit the dossier to the relevant rapporteur Member State by:
(a)
30 June 2005 at the latest for the active substances listed in Part A of Annex I;
(b)
30 November 2005 at the latest for the active substances listed in Parts B to G of Annex I.
Non-submission of dossiers
1. Where the notifier does not submit the dossier or any part thereof within the relevant time limit set out in Article 12, the rapporteur Member State shall inform the Commission and the EFSA within two months of the date of expiry of the time limit, giving any justification for the delay provided by the notifiers.
2. On the basis of the information submitted by the rapporteur Member State in accordance with paragraph 1, the Commission shall determine whether the notifier has demonstrated that the delay in the submission of the dossier was caused by force majeure .
In that case, it shall establish a new time limit for the submission of a dossier fulfilling the relevant requirements of Articles 5, 6, 9, and 10 of this Regulation in accordance with the procedure referred to in Article 19 of Directive 91/414/EEC.
3. 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 that Directive an active substance for which no dossier has been submitted within the time limit provided for in Article 12 of this Regulation or the second subparagraph of paragraph 2 of this Article. The Decision shall state the reasons for the non-inclusion.
Member States shall withdraw authorisations of plant protection products containing such active substances within the period prescribed in the Decision.
Replacement or withdrawal of notifier
1. If a notifier decides to end its participation in the programme of work for an active substance, it shall immediately inform the rapporteur Member State, the Commission, the EFSA and all other notifiers of the active substance concerned of its decision, giving the reasons.
Where a notifier ends its participation or fails to fulfil its obligations under this Regulation, the procedures provided for in Articles 15 to 24 shall be terminated as regards its dossier.
2. If a notifier agrees with another producer that the notifier shall be replaced for the purposes of further participation in the programme of work under this Regulation, the notifier and such other producer shall inform the rapporteur Member State, the Commission and the EFSA by a common declaration agreeing that such other producer shall replace the original notifier in carrying out the notifier’s duties pursuant to the relevant provisions of Articles 4, 5, 6, 9, 10, 12 and 24. They shall ensure that the other notifiers for the substance concerned are informed at the same time.
The other producer in this case shall be jointly liable with the original notifier for any fees remaining payable in relation to the notifier's application under the regime established by Member States pursuant to Article 30.
3. If all notifiers for an active substance end their participation in the programme of work a Member State may choose to act as notifier for the purposes of further participation in the programme of work.
Any Member State wishing to act as a notifier shall inform the rapporteur Member State, the Commission and the EFSA at the latest one month from the date of being informed that all notifiers have decided to end their participation and shall replace the original notifier in carrying out the notifier’s duties pursuant to the relevant provisions of Articles 4, 5, 6, 9, 10, 12 and 24.
4. All information submitted shall remain available to the rapporteur Member States, the Commission and EFSA
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
