Commission Regulation (EC) No 2229/2004 of 3 December 2004 laying down further detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EECText with EEA relevance

CHAPTER I

SUBJECT MATTER AND SCOPE, DEFINITIONS AND THE DESIGNATED MEMBER STATE AUTHORITY

Article 1

Subject matter and scope

This Regulation lays down:

(a) further detailed rules for the implementation of the fourth stage of the programme of work referred to in the second subparagraph of Article 8(2) of Directive 91/414/EEC (the programme of work) with respect to the continued evaluation of the active substances notified under Regulation (EC) No 1112/2002;

(b) rules covering the active substances that were on the market before 1 May 2004 in the Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and Slovakia and which are not included in stages one to three of the programme of work and which are not covered by Regulation (EC) No 1112/2002.

This Regulation shall apply without prejudice to:

(a) reviews by Member States of active substances listed in Annex I to this Regulation in particular pursuant to renewals of authorisations in accordance with Article 4(4) of Directive 91/414/EEC;

(b) reviews by the Commission in accordance with Article 5(5) of Directive 91/414/EEC;

(c) assessments carried out under Directive 79/117/EEC.

Article 2

Definitions

For the purpose of this Regulation, the definitions set out in Article 2 of Directive 91/414/EEC and Article 2 of Regulation (EC) No 1112/2002 shall apply.

The following definitions shall also apply:

(a) ‘notifier’ means the natural or legal person who has submitted a notification in accordance with: (i) Regulation (EC) No 1112/2002, as listed in Annex II to this Regulation, or (ii) Article 4 of this Regulation;

(b) ‘rapporteur Member State’ means the rapporteur Member State for the active substance as set out in Annex I;

(c) ‘summary dossier’ means a dossier containing the information required under Article 10(2), where summaries are given of the results of the tests and studies referred to in that paragraph;

(d) ‘complete dossier’ means a dossier containing the information required under Article 10(3), where the results of the tests and study reports referred to in the summary dossier are given in full.

Article 3

Designated Member State authority

Each Member State shall give the details concerning the designated coordinating national authority to the Commission, the EFSA and the designated coordinating national authority of each other Member State and inform them of any modifications thereof.

CHAPTER II

NOTIFICATIONS BY PRODUCERS IN NEW MEMBER STATES OF ACTIVE SUBSTANCES

Article 4

Notifications by producers in new Member States

That notification must be submitted as soon as possible, and no later than three months from the date the Commission has informed the Member States that no notification has been submitted for that active substance.

A Member State submitting such a notification shall thereafter be treated as the producer for the purposes of the evaluation of the active substance concerned.

Member States shall withdraw authorisations of plant protection products containing such active substances within the period prescribed in the Decision.

CHAPTER III

CONDITIONS FOR THE SUBMISSION OF DOSSIERS OF ACTIVE SUBSTANCES AND SUBMISSION OF INFORMATION BY THIRD PARTIES

Article 5

Submission of dossiers by more than one notifier

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.

Article 6

Submission of dossiers to the rapporteur Member State

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.

Article 7

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.

Article 8

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.

Article 9

Specific conditions for submissions of dossiers for active substances listed in Part A of Annex I

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.

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.

Article 10

Specific conditions for submissions of dossiers for active substances listed in Parts B to G of Annex I

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.

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.

Article 11

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.

Article 12

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.

Article 13

Non-submission of dossiers

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.

Member States shall withdraw authorisations of plant protection products containing such active substances within the period prescribed in the Decision.

Article 14

Replacement or withdrawal of notifier

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.

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.

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.

CHAPTER IV

EVALUATIONS OF DOSSIERS

Article 15

General Conditions for evaluations of dossiers

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).

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.

Article 16

Cooperation between Member States

Article 17

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.

Article 18

Completeness check of dossiers for substances listed in Parts B to G of Annex I

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.

Article 19

Specific conditions for evaluations of dossiers for substances listed in Parts B to G of Annex I

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.

Article 20

General conditions for draft Assessment Reports

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.

Article 21

Specific conditions for draft Assessment Reports and Recommendations to the Commission for active substances listed in Part A of Annex I

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.

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.

Article 22

Specific conditions for draft Assessment Reports and Recommendations to the Commission for active substances listed in Parts B to G of Annex I

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.

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.

Article 23

Replacement of rapporteur Member State

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.

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.

Article 24

Receipt of and access to the draft assessment report

In exceptional cases where the draft assessment report clearly does not fulfil the requirements concerning the format recommended by the Commission, the Commission shall agree with the EFSA and the rapporteur Member State on a period for resubmission of an amended report. This period shall not exceed two months.

It shall collate the comments it receives, including available comments from the EFSA, and forward them to the Commission, the Member States and the notifiers.

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 in view of the possible inclusion of the active substance in Annex I to that Directive as finalised by the EFSA where it has finalised such a list.

Article 24a

Evaluation of the draft assessment report

The Commission shall, without delay, examine the draft assessment report and the recommendation by the rapporteur Member State and the comments received from other Member States, the EFSA and from the notifiers in accordance with Article 24(2).

Article 24b

Active substances with clear indications that they do not have any harmful effects

If there are clear indications that it may be expected that the active substance does not have any harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment, as set out in Annex VI, Article 25(1)(a) and (2)(a) shall apply.

Article 24c

Consultation of the EFSA

Where the Commission requests the EFSA to carry out a full peer review, the EFSA shall deliver its conclusion at the latest six months after the request. Where the Commission does not request a full peer review, but only a conclusion on specific points, the period shall be reduced to three months. The submission of the conclusions shall in any event be no later than 30 September 2008.

The Commission may take a Decision as referred to in Article 24f.

Article 24d

Submission of additional information after the draft assessment report has been submitted to the EFSA

The rapporteur Member State shall, within one month after the receipt of such information, evaluate the information received and send its evaluation to the EFSA.

Where the rapporteur Member State, pursuant to paragraph 1 or to the first subparagraph of this paragraph, refuses to take into account studies or information received from the notifier, it shall inform the Commission and the EFSA and indicate the reasons for such refusal.

Article 24e

Withdrawal by notifier

Where Article 24b does not apply, the notifier may withdraw his support of the inclusion of the active substance in Annex I to Directive 91/414/EEC within two months from receipt of the draft assessment report referred to in Article 24(2).

Article 24f

Active substance for which there are clear indications of harmful effects

If there are clear indications that it may be expected that the active substance has harmful effects on human or animal health or on groundwater as set out in Annex VII the Commission shall take a Decision on the non-inclusion of the active substance in Annex I to Directive 91/414/EEC, in accordance with Article 25(1)(a) and (2)(b) of this Regulation.

CHAPTER V

PRESENTATION OF A DRAFT DIRECTIVE OR DRAFT DECISION CONCERNING ACTIVE SUBSTANCES AND FINALISED REVIEW REPORT

Article 25

Presentation of a draft directive or draft decision