Commission Regulation (EC) No 1490/2002 of 14 August 2002 laying down further detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC and amending Regulation (EC) No 451/2000 (Text with EEA relevance)

Article 1

Subject matter and scope

This Regulation shall apply without prejudice to:

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

(b) reviews by the Commission pursuant to 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 in Directive 91/414/EEC shall apply.

The following definitions shall also apply:

(a) ‘notifier’ means the natural or legal person who submitted a notification in accordance with the terms specified in Regulation (EC) No 451/2000 as listed in Annex II;

(b) ‘Committee’ means the Standing Committee on the Food Chain and Animal Health, referred to in Article 19 of Directive 91/414/EEC;

(c) ‘data list’ means a list of all the data which is available to be submitted in the full data package;

(d) ‘full data package’ means information and results of studies sufficient to satisfy the requirements of Annexes II and III to Directive 91/414/EEC in relation to a limited range of representative uses of the active substance concerned.

Article 3

Member State authority

Article 4

Measures in case of imbalances

If, during the assessment and evaluation referred to in Articles 9 and 10, 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, it may be decided, in accordance with the procedure provided for in Article 19 of Directive 91/414/EEC, to replace a Member State originally designated as rapporteur for a particular active substance by another Member State.

In such cases the original rapporteur Member State shall 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 fee referred to in Article 17 except for the part referred to in paragraph 2(d) thereof. The newly designated rapporteur Member State shall then require the notifiers to pay the fee referred to in Article 17 except the part referred to in paragraph 2(d) thereof.

Article 5

Withdrawal or replacement of notifier

Article 6

Submission and checking of data lists

Where, for any active substance listed in Annex I, there are several notifications, the notifiers concerned shall take all reasonable steps to submit these data lists collectively.

Where a data list is not submitted by all notifiers concerned, it shall mention the efforts made and the reasons why certain notifiers have not participated.

For active substances notified by more than one notifier those notifiers shall for each study involving vertebrate animals, detail the attempts made to avoid duplication of testing and give, if applicable, the reasons for conducting a duplicate study.

Article 7

Submission of dossiers

Where for any active substance listed in Annex I there are several notifications, the notifiers concerned shall take all reasonable steps to submit these dossiers collectively.

Where a dossier is not submitted by all notifiers concerned, it shall mention the efforts made and the reasons why certain notifiers have not participated.

For active substances notified by more than one notifier, those notifiers shall for each study involving vertebrate animals, detail the attempts made to avoid duplication of testing and give, if applicable, the reasons for conducting a duplicate study.

The summary dossier shall include the following:

(a) a copy of the notification; in the case of a joint application made by several producers, a copy of the notifications made in accordance with Article 10 of Regulation (EC) No 451/2000 and the name of the person designated by the producers concerned as being responsible for the joint dossier and the processing of the dossier in accordance with this Regulation;

(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 Directive 91/414/EEC, can be met;

(c) (i) for each point of Annex II to Directive 91/414/EEC, the summaries and results of studies and trials, the name of the person or institute that has carried out the trials; (ii) for each point of Annex III to Directive 91/414/EEC the summaries and results of studies and trials, the name of the person or institute that has carried out the trials, relevant to the assessment of the criteria referred to in Article 5 of Directive 91/414/EEC for one or more preparations which are representative for the uses referred to in subparagraph (b) taking into account that data gaps in the information of the Annex II dossier resulting from the proposed limited range of representative uses of the active substance may lead to restrictions in the inclusion into Annex I to Directive 91/414/EEC; (iii) and for active substances listed in Annex I, part B, for studies not yet fully completed the evidence that these studies have been commissioned as required by Article 10(4) of Regulation (EC) No 451/2000 with an undertaking that they will be submitted at the latest by 31 May 2005;

(d) a checklist to be filled in by the notifier, demonstrating that the dossier is complete.

Article 8

Submission of information by third parties

Any person wishing to submit information which might contribute to the evaluation, 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 to the rapporteur Member States shall do so by 30 November 2003 at the latest for substances listed in Annex I, part A, and by 30 November 2004 at the latest for substances listed in Annex I, part B. The rapporteur Member State shall submit any information received to the EFSA.

Article 9

Completeness check of dossiers

The EFSA shall assess the reports submitted to it by the rapporteur Member States and report to the Commission on the completeness of the dossiers.

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 Article 10, unless the EFSA informs the rapporteur Member State and the Commission, within two months of receipt of the Member State report on completeness, that it does not consider the dossier to be complete.

For those active substances for which the dossier is to be completed, as provided for under Article 7(2)(c)(iii), the report must confirm the date by which the dossier will be completed and by which date the evaluation as referred to in Article 10 will begin.

Article 10

Evaluation by the rapporteur Member State

At the same time, the rapporteur Member State shall make a recommendation to the Commission either:

— to include the active substance in Annex I to Directive 91/414/EEC, stating the conditions for inclusion, or

— not to include the active substance in Annex I to Directive 91/414/EEC, stating the reasons for the non-inclusion.

The rapporteur Member State shall in particular include in the draft assessment report a reference to each test and study report, for each point of Annex II and Annex III to Directive 91/414/EEC, relied on for the assessment. This 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. It shall also mention for the other notified sources of the active substances for which the dossier was considered not to be complete whether it can be concluded that such active substances are comparable within the meaning of Article 13(5) of Directive 91/414/EEC.

The rapporteur Member State may, from the start of its examination of the dossier, consult with experts from the EFSA and may request additional technical or scientific information from other Member States to assist the evaluation. The rapporteur Member State may perform the evaluation together with a co-rapporteur Member State.

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.

Article 11

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, 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 11a

Examination 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 11(2).

Article 11b

Active substance 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 V, Article 12(1)(a) and (2)(a) shall apply.

Article 11c

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 11f.

Article 11d

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 11e

Withdrawal by notifier

Where Article 11b 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 11(2).

Article 11f

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 VI, 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 12(1)(a) and (2)(b) of this Regulation.

Article 12

Presentation of a draft directive or draft decision

The Commission shall submit to the Committee a draft review report at the latest six months after:

(a) receipt of the draft assessment report where Article 11b or Article 11f applies;

(b) receipt of the conclusion established by the EFSA where Article 11c applies;

(c) receipt of a written withdrawal of the notifier’s support where Article 11e applies.

Together with the draft review report the Commission shall submit to the Committee:

(a) a draft directive including the active substance in Annex I to Directive 91/414/EEC, setting out where appropriate the conditions, including the time limit, for such inclusion; or

(b) a draft decision addressed to the Member States requiring them to withdraw, within six months, the authorisations of plant protection products containing the active substance, pursuant to the fourth subparagraph of Article 8(2) of Directive 91/414/EEC, whereby that active substance is not included in Annex I to that Directive, mentioning the reasons for the non-inclusion.

The Directive or Decision shall be adopted in accordance with the procedure referred to in Article 19(2) of Directive 91/414/EEC.

Article 12a

View by the EFSA

Where an active substance is included in Annex I to Directive 91/414/EEC pursuant to Article 11b of this Regulation, the Commission shall request the EFSA to deliver its view on the draft review report by 31 December 2010 at the latest. Member States and notifiers shall cooperate with the EFSA and the Commission.

In order to facilitate the planning of the work, the Commission and the EFSA shall agree on a schedule for the delivery of the view of the EFSA on the draft review report and on the format in which that view is submitted.

Article 13

Finalised review report

Where the Commission submits a draft directive or a draft decision in accordance with Article 12, it shall at the same time submit the conclusions of the Committee's examination in the format of a finalised review report to be noted in the summary record of the meeting. 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.

Article 14

Suspension of time limits

Where, in respect of a substance listed in Annex I, the Commission submits a proposal for a total prohibition under Directive 79/117/EEC, the time limits provided for in this Regulation shall be suspended until a decision on that proposal has been taken. Where the Council decides on the total prohibition of the substance in the Annex to Directive 79/117/EEC, the procedure under this Regulation shall be terminated.

Article 15

Measures taken by Member States

Any Member State which, on the basis of information contained in the dossiers referred to in Article 7 or in the report concerning an active substance referred to in Article 10, envisages taking action to withdraw from the market or to restrict severely the use of a plant-protection product containing that substance, shall, as soon as possible, inform the Commission, the EFSA, the other Members States and the notifiers giving the reasons for its intended action.

Article 16

Interim progress report

All Member States shall provide to the Commission and the EFSA a report of their progress on the evaluation of the active substances for which they are rapporteur. Such report shall be made by 30 November 2004 for the active substances mentioned in Annex I, part A, and by 30 November 2005 for those of Annex I, part B.

Article 17

Fees

For this purpose, the Member States shall:

(a) require the payment of a fee or charge for each submission of a dossier;

(b) ensure that the amount of the fee or charge shall be established in a transparent manner with the view to correspond to the real cost of the examination and administrative treatment of a dossier; however this does not exclude that Member States provide for a scale of fixed charges based on average costs for the calculation of the total fee;

(c) ensure that the fee or charge is received in accordance with the instructions given by the organisation in each Member State listed in Annex IV and that the income from the fee or charge is used to finance exclusively the costs actually incurred by the Member State for the evaluation and administrative treatment of the dossiers for which that Member State is rapporteur or to finance general activities of the Member States resulting from Articles 9, 10 or 11;

(d) require that a first part of the fee or charge, covering the costs of the rapporteur Member State's obligations resulting from Article 6 and Article 9 is paid at the time of the submission of the data lists referred to in Article 6; this part will not be refundable under any circumstance.

Article 18

Other charges, taxes, levies or fees

Article 17 is without prejudice to Member States' rights to maintain or introduce, to the extent permitted under the Treaty, charges, taxes, levies or fees with regard to authorisation, placing on the market, use and control of active substances and plant-protection products other than the fee provided for in Article 17.

Article 19

Temporary measures

If necessary and on a case-by-case basis, the Commission may take appropriate temporary measures as provided for by the third subparagraph of Article 8(2) of Directive 91/414/EEC for uses for which additional technical evidence has been provided demonstrating the essential need for further use of the active substance and that there is no efficient alternative.

Article 20

Amendment to Regulation (EC) No 451/2000

Regulation (EC) No 451/2000 is amended as follows:

‘Article 8 Evaluation of dossiers by rapporteur Member States and the EFSA