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.
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.
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.
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.
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.
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
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
