COMMISSION REGULATION (EC) No 451/2000
of 28 February 2000
laying down the detailed rules for the implementation of the second and third stages of the work programme referred to in Article 8(2) of Council Directive 91/414/EEC
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(1), as last amended by Commission Directive 1999/80/EC(2), and in particular Article 8(2), second subparagraph, thereof,
Whereas:
(1) The Commission is to undertake a work programme for the gradual examination of active substances on the market two years after the date of notification of Directive 91/414/EEC within a period of 12 years. The first stage of the programme was laid down by Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the work programme referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market(3), as last amended by Regulation (EC) No 1972/1999(4). The first stage is ongoing. It is necessary to continue and speed up the examination of the remaining active substances, taking into account experience from the first stage.
(2) Given the very high number of existing active substances on the market still to be evaluated, a programme in several phases must be established. Experience has shown that the evaluation and decision-making on an active substance is a time-consuming process. It is therefore not yet possible to provide for a detailed evaluation of all the existing active substances.
(3) Therefore the second stage will provide for the detailed evaluation of a number of active substances comparable to the number covered in the first stage whilst the third stage will prepare for the subsequent evaluation of active substances. For certain categories of active substances further harmonisation is required concerning the dossier to be provided and the evaluation to be carried out. Those categories should therefore not be included in the current proposed work programme but should be covered by further stages for their evaluation with a view to their possible inclusion in Annex I to Directive 91/414/EEC.
(4) For the second stage a selection should be made taking into account, in a balanced manner, such aspects as health and/or environmental concern, possibility of leaving residues in treated products, importance of the preparations containing these substances for agriculture, any manifest data gaps and any similarity of chemical or biological properties.
(5) The relationships between producers, Member States and the Commission and the obligations on each of the parties for the implementation of the programme should be laid down, taking into account experience gained during the first stage of the programme. Close cooperation between all parties involved is necessary to increase the efficiency of the programme.
(6) Technical or scientific information about an active substance, in particular with regard to its potentially dangerous effects or its residues, submitted within the relevant time limits by any other interested parties should also be taken into consideration in the evaluations.
(7) A notification procedure should be provided by which interested producers have the right to inform the Commission of their interest in securing the inclusion of an active substance in Annex I to Directive 91/414/EEC and of their undertaking to submit all the required information for a proper evaluation of, and decision on, that active substance in the light of the criteria for inclusion set out in Article 5 of Directive 91/414/EEC. Therefore the information submitted should include information on a limited range of representative uses for which the notifier must demonstrate, on the basis of the data submitted, that for one or more preparations the requirements of Directive 91/414/EEC in relation to the criteria referred to in its Article 5 can be met.
(8) It is necessary to define the obligations of notifiers with regard to the formats, periods and recipient authorities for the information to be submitted.
(9) The task of evaluation should be distributed among the competent authorities of the Member States. Therefore, for each active substance a rapporteur Member State should be designated to examine and evaluate the information submitted and to present to the Commission the results of the evaluation and a recommendation for a decision to be taken with regard to the active substance concerned.
(10) Rapporteur Member States should first examine dossiers received, assess the completeness check provided by the notifiers and report to the Commission. It should be established that Member States should send draft reports of their evaluations to the Commission generally within 12 months after the dossiers submitted by notifiers have been considered complete.
(11) The draft reports prepared by the rapporteur Member States should, where necessary, be the subject of preliminary examination by experts of other Member States within a programme coordinated by the Commission before they are submitted to the Standing Committee on Plant Health.
(12) In order to avoid duplication of work, and in particular experiments involving vertebrate animals, producers should be encouraged to submit collective dossiers.
(13) The notification and submission of a dossier should not be a prerequisite for the possibility after inclusion of the active substance in Annex I to Directive 91/414/EEC to place plant protection products on the market subject to the provisions of Article 13 of Directive 91/414/EEC. Therefore, it should be possible for operators which have not presented notifications to be informed at all stages of the possible further requirements for continued marketing of plant protection products containing an active substance under evaluation.
(14) The procedures provided for in this Regulation should not prejudice procedures and actions to be undertaken in the framework of other Community legislation, in particular, under Council Directive 79/117/EEC of 21 December 1978 prohibiting the placing on the market and use of plant protection products containing certain active substances(5), as last amended by Commission Directive 91/188/EEC(6), where information becomes available to the Commission showing that its requirements may be satisfied.
(15) Directive 91/414/EEC provides in Article 8(2), second subparagraph, a 12-year period for the work programme concerning the evaluation of existing active substances. The 12-year period may be extended by the Commission subject to the conclusions of a progress report, referred to in Article 8(2), third subparagraph, on the programme to the European Parliament and the Council. On the expiry of the time limit, whether or not it was extended, Member States will have to withdraw authorisations of plant protection products containing the active substances which were not included in Annex I to Directive 91/414/EEC.
The Commission, subject to the conclusions of that report, will adopt further detailed regulatory provisions serving to finalise as soon as possible the evaluation and decision making of active substances for which the provisions of the present Regulation concerning notification and submission of complete dossiers axe satisfied.
Article 8(2), fourth subparagraph, of Directive 91/414/EEC provides for a Commission Decision not to include in Annex I active substances in cases where the requirements of Article 5 of Directive 91/414/EEC are not satisfied or the requisite information and data have not been submitted within the prescribed time period and for the withdrawal by Member States of authorisations of plant protection products containing such active substances. However, subject to the conclusions of the said report and if necessary, it may be appropriate to re-examine these provisions for certain uses which are essential and for which there is no alternative to protect efficiently plants or plant products such as to allow the development of alternatives replacing the use of withdrawn products. The necessity of re-examining those provisions will have to be demonstrated on a case-by-case basis.
(16) If, for a particular active substance, the requirements of the present Regulation concerning notification and submission of complete dossiers are not satisfied, interested parties are not prevented from seeking inclusion of such active substances in Annex I to Directive 91/414/EEC, in accordance with the procedures under Article 6(2) of Directive 91/414/EEC, at a later date.
(17) A third stage of work is envisaged for all the active substances not covered by the first and second stage of the programme. Producers wishing to secure the inclusion of such active substances in Annex I to Directive 91/414/EEC should provide detailed information relating to the current stage of completeness of their dossiers and on the endpoints, which would be useful for further prioritisation of the work programme, and undertake to provide a full data package. It is also appropriate to indicate now the time limit for submission of the full data package.
(18) It is necessary to inform the producers as early as possible about future stages of the re-evaluation programme by publishing the active substances which will be included in the third stage of the programme in order to facilitate the submission of collective dossiers and the preparation of the necessary studies and data.
(19) In order to ensure the proper implementation of this work programme, a fee should be paid to the rapporteur Member States for the detailed evaluation of notifications and dossiers. The cost structure in the Member States is not the same. It is therefore not possible to harmonise completely the amount of such fees. A fee should also be paid to the authority designated by the Commission to examine the notifications for the active substances covered by the third stage.
(20) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plant Health,
HAS ADOPTED THIS REGULATION:
CHAPTER 1
GENERAL PROVISIONS AND DEFINITIONS
Article 1
Scope
1. This Regulation lays down detailed rules for the implementation of the second and third stages of the work programme referred to in Article 8(2) of Directive 91/414/EEC, hereinafter referred to as "the Directive".
2. The second stage concerns the evaluation of the active substances listed in Annex I to this Regulation with a view to their possible inclusion in Annex I to the Directive.
3. The third stage concerns the reporting of the active substances referred to in Annex II to this Regulation with a view to their possible inclusion at a later stage in a subsequent priority list of active substances with a view to their possible inclusion in Annex I to the Directive.
4. Article 6(2), Article 6(3) and the second subparagraph of Article 6(4) of the Directive shall not apply to a substance listed in Annexes I and II to this Regulation as long as the procedures provided for in this Regulation with regard to that substance have not been finalised.
5. This Regulation shall apply without prejudice to:
(a) reviews by Member States in particular pursuant to renewals of authorisations in accordance with Article 4(4) of the Directive;
(b) reviews by the Commission pursuant to Article 5(5) of the Directive;
(c) assessments carried out under Directive 79/117/EEC.
Article 2
Definitions
1. For the purpose of this Regulation, plant protection products, substances, active substances, preparations and authorisations of plant protection products shall have the meanings defined in Article 2 of the Directive.
2. For the purpose of this Regulation, the following definitions shall also apply:
(a) "producer" means:
- for active substances produced within the Community, the manufacturer or a person established within the Community designated by the manufacturer as his sole representative for the purpose of compliance with this Regulation,
- for active substances produced outside the Community, the person established within the Community and designated by the manufacturer as his sole representative within the Community for the purpose of compliance with this Regulation,
- for active substances for which a joint notification or joint dossier is submitted, the association of producers established within the Community and designated by the producers referred to in the first or second indent for the purpose of compliance with this Regulation;
(b) "manufacturer" means the person who manufactures the active substance on his own or who contracts out to another party the manufacturing of the active substance on his behalf;
(c) "committee" means the Standing Committee on Plant Health, referred to in Article 19 of the Directive.
Article 3
Member State authority
1. Member States shall allocate responsibility for the implementation of their obligations under the work programme referred to in Article 8(2) of the Directive to an authority or authorities.
2. In each Member State one authority, which is referred to in Annex III, shall coordinate and ensure all necessary contacts with producers, other Member States and the Commission pursuant to this Regulation. Each Member State shall inform the Commission and the designated coordinating authority of each other Member State of any modifications to the communicated details concerning the designated coordinating authority.
CHAPTER 2
SECOND STAGE OF THE WORK PROGRAMME
Article 4
Notification
1. Any producer wishing to secure the inclusion of an active substance referred to in Annex I to this Regulation, or any variants thereof such as salts, esters or amines, in Annex I to the Directive shall so notify, for each active substance separately, the rapporteur Member State designated in Annex I to this Regulation within six months after the date of entry into force of this Regulation.
2. Notification must be made on paper and sent by registered mail to the coordinating authority in the rapporteur Member State, referred to in Annex III to this Regulation, in accordance with the model notification as shown in Part 1 of Annex IV to this Regulation. A copy of the notification shall be sent to the European Commission, Health and Consumer Protection DG, Rue de la Loi/Wetstraat 200, B-1049 Brussels.
3. Any producer who has not notified any given active substance referred to in paragraph 1 within the time limit referred to in that paragraph or whose notification was rejected in accordance with the provisions of Article 5(2) shall be permitted to participate in this programme only collectively with one or more notifiers of the active substance, whose notification was accepted in accordance with Article 5(2), in submitting a joint dossier.
Article 5
Examination of notifications and request for submission of dossiers to designated rapporteur Member States
1. For each active substance for which a Member State has been designated rapporteur, it shall examine the notifications referred to in Article 4(2) and, at the latest three months after the time limit referred to in Article 4(1), report to the Commission on the admissibility of the notifications received taking into account the criteria as referred to in Annex V, Part 1.
2. The Commission shall refer the reports referred to in paragraph 1 within three months from the receipt thereof to the committee for further examination concerning their admissibility, taking into account the criteria as referred to in Annex V, Part 1.
Following that examination, a regulation shall be adopted in accordance with the procedure laid down in Article 19 of the Directive establishing the list of active substances, adopted for evaluation with a view to their possible inclusion in Annex I to the Directive. Only active substances for which at least one notification was considered admissible in accordance with the provisions of the first subparagraph shall be included in that Regulation.
3. In the list referred to in paragraph 2, certain active substances with similar structures or chemical properties may be grouped together; if an active substance has been notified with different compositions which may lead to different toxicological properties or have different environmental effects, those compositions may be listed separately.
4. For each active substance adopted for assessment, the Regulation referred to in paragraph 2 shall specify:
(a) the names and addresses of all notifiers who have made notifications in accordance with Article 4(1) and (2) and which have been considered to be admissible following their examination in accordance with the first subparagraph of paragraph 2;
(b) the name of the Member State designated as rapporteur; this will be the same Member State as the one designated in Annex I unless an imbalance has become apparent in the number of active substances attributed to the different Member States;
(c) the time limit for the submission to the rapporteur Member State of the dossiers referred to in Article 6, which shall be a period of 12 months;
(d) the same time limit for the submission to the rapporteur Member States by any interested parties of relevant information which may 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.
5. From the time of the adoption of the Regulation referred to in paragraph 2, if a Member State envisages taking action to withdraw from the market or to restrict severely the use of a plant protection product containing an active substance listed in that Regulation, where that action is based on information contained in the dossiers referred to in Article 6 or the report referred to in Article 8, the Member State shall inform the Commission and the other Members States as soon as possible, citing the reasons for its intended action.
6. When, during the assessment and evaluation referred to in Articles 6 and 7, an imbalance becomes apparent in the responsibilities borne by the Member States as rapporteurs, it may be decided, in accordance with the procedure laid down in Article 19 of the Directive, 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 the fee referred to in Article 12, except the part referred to in Article 12(2)(d) to the notifiers concerned. The newly designated rapporteur Member State shall then require the notifiers to pay the fee referred to in Article 12, except the part referred to in Article 12(2)(d).
7. When a notifier decides to end its participation in the work programme for an active substance, he shall inform at the same time the rapporteur Member State, the Commission and the other notifiers for the substance concerned, mentioning the reasons. Where a notifier ends his participation or fails to fulfil his obligations provided for in this Regulation, the procedures provided for in Article 7 or Article 8 shall not be continued for his dossier.
When a notifier agrees with another producer that the notifier shall be replaced for the purposes of further participation in the work programmes under this Regulation, the notifier and the other producer shall inform the rapporteur Member State and the Commission by a common declaration, agreeing that the other producer shall replace the original notifier in carrying out the notifier's duties as set out in Articles 6, 7 and 8; they shall ensure that the other notifiers for the substance concerned are informed at the same time. In such a case, the other producer may be liable for any fees remaining payable under the regime established by the rapporteur Member State pursuant to Article 12.
Article 6
Submission of dossiers by notifiers
1. Within the time limit referred to in Article 5(4)(c), for each active substance the notifiers specified in the Regulation referred to in that Article shall, individually or collectively, submit to the designated authority of the rapporteur Member State for any given active substance the complete dossier referred to in paragraph 3, including the summary dossier referred to in paragraph 2.
Where for any substance the Regulation referred to in Article 5 indicates several notifications, the notifiers concerned shall take all reasonable steps to present collectively the dossiers as referred to in the first subparagraph.
Where a dossier was not presented by all notifiers concerned, it shall mention the efforts made and the reasons why certain producers have not participated.
2. 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 4 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 for which it has to be demonstrated by the notifier, on the basis of the data submitted, that for one or more preparations the requirements of the Directive in relation to the criteria referred to in Article 5 thereof can be met;
(c) - for each point of Annex II to the Directive, the summaries and results of studies and trials, and the name of the person or institute that has carried out the trials,
- the same information for each point of Annex III to the Directive relevant to the assessment of the criteria referred to in Article 5 of the Directive for one or more preparations which are representative for the uses referred to in subparagraph (b) taking into account the fact 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 in Annex I to the Directive,
- for studies not yet fully completed, the evidence that these studies have been commissioned at the latest three months after the entry into force of this Regulation with an undertaking that they will be submitted at the latest within 12 months after the time limit referred to in Article 5(4)(c);
(d) a check by the notifier of the completeness of the dossier.
3. The complete dossier shall contain physically the individual test and study reports concerning all the information referred to in paragraph 2(c), or the protocols and the undertakings referred to in paragraph 2(c) where work is in progress.
4. Member States shall determine the number of copies and the format of the dossiers referred to to in paragraphs 2 and 3 to be submitted by the notifiers. In determining the format of the dossier, Member States shall take the utmost account of the recommendations made by the Commission in the framework of the Standing Committee on Plant Health.
5. Where, for any given active substance, the dossiers referred to in paragraph 1 are not sent within the time limit referred to in Article 5 (4)(c), the rapporteur Member State shall inform the Commission at the latest within three months, giving the reasons pleaded by the notifiers.
6. On the basis of the report of the rapporteur Member State referred to in paragraph 5, a new time limit shall only be established in accordance with the procedure laid down in Article 19 of the Directive in the Regulation referred to in Article 5 for the submission of a dossier fulfilling the requirements of paragraphs 2 and 3 where the delay is demonstrated to have been caused by force majeure.
7. After that examination, the Commission shall decide, as provided for in Article 8(2), fourth subparagraph, of the Directive, not to include in Annex I to the Directive an active substance for which no notification or no dossier has been submitted within the prescribed time limit mentioning the reasons for the non-inclusion. Member States shall withdraw by 25 July 2003 authorisations of plant protection products containing those active substances.
Article 7
Completeness check of dossiers
1. For each active substance for which it has been designated rapporteur, the Member State shall:
(a) examine the dossiers referred to in Article 6(2) and (3) and assess the completeness check(s) provided by the notifiers;
(b) at the latest six months after the receipt of all dossiers for an active substance, 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 within the meaning of Article 6(2) and (3), the rapporteur Member State shall perform the evaluation as referred to in Article 8, unless the Commission informs the rapporteur Member State within two months that the dossier is not to be considered complete. For those active substances for which the dossier is to be completed, as provided for under Article 6(2)(c), third indent, the report must confirm the date by which the dossier is to be completed and from which the evaluation as referred to in Article 8 will begin.
2. For those active substances for which a rapporteur Member State or the Commission consider that no dossier is complete within the meaning of Article 6(2) and (3), the Commission shall, within three months after the receipt of the report of the rapporteur Member State referred to in paragraph (1)(b), refer that report to the committee. In accordance with the procedure laid down in Article 19 of the Directive it shall be decided whether a dossier is considered complete within the meaning of Article 6(2) and (3). Where the dossier is considered complete, the rapporteur Member State shall perform the evaluation referred to in Article 8.
3. After that examination, the Commission shall decide, as provided for in Article 8(2), fourth subparagraph, of the Directive, not to include in Annex I to the Directive active substances for which no complete dossier has been submitted within the prescribed time limit mentioning the reasons for the non-inclusion. Member States shall withdraw by 25 July 2003 authorisations of plant protection products containing those active substances.
Article 8
Evaluation of dossiers by rapporteur Member States and the Commission
1. The rapporteur Member State shall evaluate and report only on those dossiers which are considered to be complete within the meaning of Article 6(2) and (3). It shall for the other dossiers check the identity and impurities of the active substance. The rapporteur Member State shall take into consideration the information available in the other dossiers submitted by a notifier or by any interested party in accordance with the provisions of Article 5(4)(d). It shall send to the Commission as quickly as possible, and at the latest 12 months after the dossier has been considered to be complete, a report on its evaluation of the dossier. The report shall be presented in the format recommended by the Commission in the framework of the Standing Committee on Plant Health and shall include a recommendation:
- either to include the active substance in Annex I to the Directive stating the conditions for inclusion,
- or not to include the active substance in Annex I to the Directive, mentioning the reasons for the non-inclusion.
The rapporteur Member State shall in particular include in the report a reference to each test and study report for each point of Annex II and Annex III to the Directive relied on for the assessment 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 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 the Directive.
2. Without prejudice to Article 7 of the Directive, submission of new studies shall not be accepted, except for the studies as referred to in Article 6(2)(c), third indent. The rapporteur Member State may request the notifiers to submit further data which are necessary to clarify the dossier. The request by the rapporteur Member State for the submission of further data necessary to clarify the dossier shall not affect the time limit for the submission of the report referred to in paragraph 1.
The rapporteur Member State may, from the start of the examination, consult with experts from one or several Member States and may request additional technical or scientific information from other Member States in order to assist the evaluation.
The rapporteur Member State shall ensure that notifiers submit the updated summary dossiers to the Commission and the other Member States at the same time as the rapporteur's report of the evaluation of the updated dossiers is sent to the Commission.
The Member States or the Commission may request through the rapporteur Member State that notifiers also send them the updated complete dossiers or parts thereof.
3. After receiving the summary dossier and the report referred to in paragraph 1, the Commission shall refer the dossier and the report to the Standing Committee on Plant Health for examination.
Before referring the dossier and the report to the Committee, the Commission shall circulate the rapporteur's report to the Member States for information and may organise a consultation of experts from one or several Member States. The Commission may consult some or all of the notifiers of active substances specified in the Regulation referred to in Article 5(2) on the report or parts of the report on the relevant active substance. The rapporteur Member State shall ensure the necessary technical and scientific assistance during these consultations.
Without prejudice to Article 7 of the Directive, submission of new studies will not be accepted except for the studies as referred to in Article 6(2)(c), third indent. The rapporteur Member State, after consultation with the Commission, may request the notifiers to submit further data necessary to clarify the dossier.
The Commission shall consult the relevant scientific committee(s) on any matters relating to health and the environment before submitting to the committee the draft directive or draft decision referred to in paragraph 4.
The rapporteur Member State shall make available on specific request or keep available for consultation by interested parties the following:
(a) the information referred to in the second subparagraph of paragraph 1, except for the elements thereof which have been accepted as confidential in accordance with Article 14 of the Directive;
(b) the name of the active substance;
(c) the content of the pure active substance in the manufactured material;
(d) the list of any data required for consideration of the possible inclusion of the active substance in Annex I to the Directive, first as contained in the rapporteur's report and secondly as finalised after consultation by the Commission, where appropriate, of the experts referred to in the second subparagraph.
4. After the examination referred to in paragraph 3, the Commission shall, without prejudice to any proposal it may submit with a view to amending the Annex to Directive 79/117/EEC, adopt in accordance with the procedure laid down in Article 19 of the Directive:
(a) a directive serving to include the active substance in Annex I to the Directive, setting out where appropriate the conditions, including the time limit, for such inclusion; or
(b) a decision addressed to the Member States withdrawing the authorisations of plant protection products containing the active substance, pursuant to the fourth subparagraph of Article 8(2) of the Directive, whereby that active substance is not included in Annex I to the Directive, mentioning the reasons for the non-inclusion.
5. When the Commission submits to the committee the draft directive or draft decision referred to in paragraph 4, it shall at the same time present the conclusions of the committee's examination in the format of an up-dated review report to be noted in the summary record of the meeting.
The review report, excluding any parts which refer to confidential information contained in the dossiers and determined as such in accordance with Article 14 of the Directive, shall be made available by each Member State on specific request, or shall be kept available for consultation by interested parties.
Article 9
Suspension of evaluation
Where, in respect of a substance mentioned in Annex I to this Regulation, the Commission presents 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 under Directive 79/117/EEC, the procedure under this Regulation shall be terminated.
CHAPTER 3
THIRD STAGE OF THE WORK PROGRAMME
Article 10
Notification
1. Any producer wishing to secure the inclusion of an active substance referred to in Annex II to this Regulation, in Annex I to the Directive shall so notify the body referred to in Annex VII to this Regulation. The Commission shall give regular follow-up of the tasks mentioned in Annex VII to this Regulation entrusted to the body referred to in that Annex. In accordance with the procedure laid down in Article 19 of the Directive it may be decided to designate another body if it appears that the tasks are not adequately performed.
2. Notifications shall be submitted for each active substance separately, as follows:
(a) within three months of the date of entry into force of this Regulation, a first notification in accordance with Section 1 of the model notification as shown in Annex IV, Part 2 hereto;
and
(b) within nine months of the date of entry into force of this Regulation, a second notification in accordance with Sections 1 and 2 of the model notification as shown in Annex IV, Part 2 hereto, including a written commitment to present a complete dossier.
3. Detailed provisions concerning the submission of such dossiers, the time limit(s) for their submission and the fee regime for the active substances concerned shall be established by the Commission in a Regulation to be adopted in accordance with Article 8(2), second subparagraph, of the Directive.
4. The time limit for the submission of a full data package shall be 25 May 2003 at the latest. The full data package shall contain physically the individual test and study reports concerning all the information referred to in Article 6(2)(c), first and second indents. Nevertheless, in the Regulation referred to in paragraph 3, a later time limit may be established in exceptional cases for the results of long-term studies, not expected to be fully completed by that date, provided that the data package contains:
- evidence that such studies have been commissioned at the latest within 12 months of the date of the entry into force of this Regulation,
- a due scientific justification,
- the protocol and a progress report of the study.
5. Any producer who has not notified any given active substance referred to in paragraph 1 within the time limits referred to in paragraph 2 or whose notification was rejected in accordance with Article 11 will be permitted to participate in the review programme only collectively with one or more notifiers of the active substance, whose notification was considered admissible in accordance with Article 11, in submitting a joint dossier.
Article 11
Examination of notifications
1. The Commission shall, within three months after the time limit referred to in Article 10(2)(b), inform the committee of the notifications received in time. At the latest eight months after the receipt of the notifications, the commission will report to the Committee for further examination on the admissibility of the notifications received taking into account the criteria as referred to in Annex V, Part 2.
2. The Commission shall decide, as provided for in Article 8(2), fourth subparagraph of the Directive, not to include in Annex I to the Directive active substances referred to in Annex II to this Regulation for which no admissible notification or no full data package has been submitted within the prescribed time limit mentioning the reasons for the non-inclusion. Member States shall withdraw by 25 July 2003 authorisations of plant protection products containing those active substances.
CHAPTER 4
FEES
Article 12
Fees for the second priority list
1. Member States shall establish a regime obliging the notifiers to pay a fee for the administrative treatment and the evaluation of notifications as well as the dossiers related thereto, which have been submitted to them in accordance with Article 4 or Article 6 in each case where the Member State has been designated as the rapporteur Member State.
2. For this purpose, the Member States shall:
(a) require the payment of a fee for each notification, whether introduced by one notifier or collectively by several interested notifiers, as well as for each submission of a dossier related thereto;
(b) ensure that the amount of the fee is established in a transparent manner with a view to corresponding to the real cost of the examination and administrative treatment of a notification and a dossier; however, Member States may provide for a scale of fixed charges based on average costs for the calculation of the total fee;
(c) ensure that the fee is received in accordance with the instructions given by the organisation in each Member State listed in Annex VI and that the income from the fee is used to finance exclusively the costs actually incurred by the rapporteur Member State for the evaluation and administrative treatment of the notifications and the dossiers for which that Member State is rapporteur or to finance general actions for the implementation of its obligations as rapporteur Member State resulting from Article 7 or Article 8;
(d) require that a first part of the fee, covering the costs of the rapporteur Member State's obligations resulting from Article 5(1) and Article 7, is paid at the time of the submission of the notification referred to in Article 4; this part shall not be refundable under any circumstances.
Article 13
Fees for the notification for the third stage of the work programme
Any producers submitting a notification in accordance with Article 10 shall at the time of the submission of their first notification, as referred to in Article 10(2)(a), pay a fee of EUR 5000 for each active substance to the body referred to in Annex VII. The fee shall be used to finance exclusively the costs actually incurred for the tasks referred to in Annex VII.
Article 14
Other charges, levies or fees
Articles 12 and 13 are without prejudice to Member States' rights to maintain or introduce, in accordance with the Treaty, charges, levies or fees with regard to the authorisation, placing on the market, use and control of active substances and plant protection products other than the fee provided for in Articles 12 and 13.
CHAPTER 5
FINAL PROVISIONS
Article 15
Temporary measures
The Commission shall report to the committee on the conclusions of its progress report, referred to in Article 8(2), third subparagraph, of the Directive.
If necessary and on a case-by-case basis, the Commission may take appropriate temporary measures as provided for by Article 8(2), third subparagraph, of the Directive 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 16
Entry into force
This Regulation shall enter into force on 1 March 2000.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 28 February 2000.