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/EEC
(Text with EEA relevance)
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), and in particular the second subparagraph of Article 8(2) thereof,
Whereas:
(1)
Directive 91/414/EEC provides for the Commission to undertake a programme of work within a period of 12 years (the programme of work) following the notification of that Directive for the gradual examination of active substances on the market two years after the date of notification of that Directive.
(2)
Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (2) provides for the first stage of the programme of work and is still ongoing.
(3)
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 (3) provides for the second stage of the programme of works and is also ongoing.
(4)
Regulation (EC) No 451/2000 also provides for a third stage of the programme of works for an additional number of active substances not covered by the first and second stages of the programme. 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 451/2002 (4) also provides for the third stage of the programme of works. The third stage is also ongoing.
(5)
Commission Regulation (EC) No 1112/2002 of 20 June 2002 laying down the 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/EEC (5) provides for the fourth stage of work and is ongoing. Producers wishing to support the inclusion of the active substances covered by that stage in Annex I to Directive 91/414/EEC have undertaken to provide the necessary information.
(6)
By reason of the accession of the Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and Slovakia, it is necessary to provide the opportunity for producers in those new Member States to notify their interest to participate in stage four of the programme of work for all substances covered under that stage. It is also appropriate to organise the review of substances that were on the market in a new Member State before 1 May 2004 and which are not included in stages one to four of the programme of work.
(7)
The procedures established 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 (6), where information becomes available to the Commission showing that its requirements may be satisfied.
(8)
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (7) created the European Food Safety Authority (EFSA) to ensure that the Community has access to high-quality, independent and efficient scientific and technical support in order to achieve a high level of health protection in relation to legislation concerning safety of food and feed. It is therefore appropriate to provide that the EFSA should have a role in the programme of work on active substances.
(9)
The relationships between producers, Member States, the Commission and the EFSA and the obligations on each of them for the implementation of the programme of work should be laid down, taking into account experience gained during the first and second stages of the programme of work, the objective of separating risk assessment from risk management and the need to organise the work in the most efficient way.
(10)
Close cooperation between producers, Member States, the Commission and the EFSA and a scrupulous respect of time limits laid down is necessary to ensure the efficiency of the programme of work. Strict time limits for all elements of the fourth stage of that programme should be set in order to ensure its finalisation within an acceptable time period. For certain active substances where the dossier requirements are limited, a short deadline for submission of the dossier is appropriate in order to allow the opportunity for further information to be provided within the overall time-frame for completion of the review programme.
(11)
In order to avoid duplication of work, and in particular experiments involving vertebrate animals, producers should be encouraged to submit collective dossiers.
(12)
It is necessary to define the obligations of producers with regard to the formats, time periods and national authorities and the EFSA for the information to be submitted. Many of the active substances covered by stage four of the programme of work are produced in small volume for specialist purposes. Some are important in organic or other low input farming systems and may be expected to constitute a low risk in terms of human and environmental protection.
(13)
The Commission identified in its progress Report to the European Parliament and the Council - Evaluation of the active substances of plant protection products (submitted in accordance with Article 8(2) of Council Directive 91/414/EEC on the placing of plant protection products on the market) (8) the need for special measures to be adopted in relation to low-risk compounds.
(14)
A modified approach is required for this stage of the programme of work to reduce the risk that large numbers of active substances will be withdrawn for economic reasons alone. For certain groups of active substances it is, therefore, appropriate that the format and requirements for the information to be submitted are different from those developed for active substances in the previous three stages of the programme of work.
(15)
In the interests of consistency of Community legislation it is necessary to ensure that the measures provided for in this Regulation are coherent with measures taken under Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (9).
(16)
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 that Directive. Therefore persons who have not submitted notifications should be able to be informed at all stages of the evaluation process of the possible further requirements for continued marketing of plant protection products containing an active substance under evaluation.
(17)
In order to ensure that all relevant information on the potentially dangerous effects of an active substance or its residues are considered, technical or scientific information submitted within the relevant time limits by any person should also be taken into consideration in the evaluations.
(18)
Where cooperation with notifiers ceases, it is impossible to continue further evaluation efficiently and therefore the evaluation of an active substance should be terminated unless a Member State takes over.
(19)
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. Where appropriate the rapporteur Member State should assess the completeness checklist provided by the notifier, and examine and evaluate the information submitted. It should present to the EFSA the results of the evaluation and make a recommendation to the Commission concerning the decision to be taken with regard to the active substance concerned. For certain groups of active substances it is appropriate that the rapporteur Member States closely cooperate with other rapporteur Member States for that group. For each group it is appropriate to identify a lead rapporteur to coordinate such cooperation.
(20)
Rapporteur Member States should send draft assessment reports of their evaluations of active substances to the EFSA. The draft assessment reports should be peer reviewed by the EFSA before they are submitted to the Commission.
(21)
In case of an apparent imbalance in the responsibilities borne by the Member States as rapporteur in the evaluation and assessment, it should be possible to replace the Member State originally designated as rapporteur for a particular active substance by another Member State.
(22)
To ensure the proper resourcing of this stage of the programme of work, a fee should be paid to the Member States for the handling and evaluation of dossiers and draft assessment reports.
(23)
The EFSA has been consulted on the proposed measures.
(24)
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS REGULATION:
CHAPTER I
SUBJECT MATTER AND SCOPE, DEFINITIONS AND THE DESIGNATED MEMBER STATE AUTHORITY
Article 1
Subject matter and scope
1. 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.
2. Article 6(2) and (3) and the second paragraph of Article 6(4) of Directive 91/414/EEC shall not apply to active substances listed in Annex I to this Regulation as long as the procedures provided for in this Regulation with regard to such substances have not been finalised.
3. 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
1. Each Member State shall designate an authority or authorities to carry out the obligations of the Member States as defined in this Regulation.
2. The national authorities listed in Annex III shall coordinate and ensure all necessary contacts with notifiers, other Member States, the Commission and the European Food Safety Authority (EFSA) in accordance with this Regulation.
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
1. Any producer in a new Member State referred to in Article 1(1)(b) of this Regulation wishing to secure the inclusion in Annex I to Directive 91/414/EEC of an active substance listed in Annex I to this Regulation shall notify the details set out in Annex V of this Regulation to the Commission, other notifiers for that substance and the rapporteur Member State at the latest three months from the date of entry into force of this Regulation.
2. Any producer making a notification under paragraph 1 shall fulfil the obligations of producers or notifiers set out in this Regulation for the active substance notified.
3. Where a producer in a new Member State has not submitted a notification for an active substance listed in Annex I to this Regulation, in accordance with paragraph 1, it shall only be permitted to participate in the programme of work collectively with one or more notifiers of the active substance, including a Member State which has notified in accordance with paragraph 4 of this Article.
4. Where no notification has been received for an active substance listed in Annex I to this Regulation, a new Member State may declare its interest in supporting the inclusion of that active substance in Annex I to Directive 91/414/EEC by notifying the Commission and the rapporteur Member State.
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.
5. The Commission shall decide, as provided for in the fourth subparagraph of Article 8(2) of Directive 91/414/EEC, not to include in Annex I to that Directive active substances referred to in Annex I to this Regulation for which no notification has been submitted in accordance with paragraphs 1 or 4 of this Article. The Decision shall state the reasons for the non-inclusion.
Member States shall withdraw authorisations of plant protection products containing such active substances within the period prescribed in the Decision.
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
1. Where for any active substance listed in Annex I there is more than one notifier, the notifiers concerned shall take all reasonable steps to submit the dossier for such substance collectively.
Where the dossier is not submitted by all such notifiers, it shall contain details of the efforts made and the reasons why certain notifiers have not participated in the submission of the dossier.
2. Where an active substance has been notified by more than one notifier, those notifiers shall, for each study involving vertebrate animals, give details of the attempts made to avoid duplication of testing and give, if applicable, the reasons for conducting a duplicate study.
Article 6
Submission of dossiers to the rapporteur Member State
1. The notifier shall submit the dossier for the active substance (the dossier) to the rapporteur Member State.
2. The dossier shall include the following:
(a)
a copy of the notification; in the case of a collective notification made by more than one producer as referred to in Article 5(1), it shall include:
(i)
a copy of the notifications made in accordance with Article 4 or 5 of Regulation (EC) No 1112/2002 or Article 4 of this Regulation;
(ii)
the name of the person designated by the producers concerned as being responsible for the collective notification who will act as a contact point during the procedure;
(b)
a limited range of representative uses of the active substance, in respect of which the data submitted by the notifier in the dossier shall demonstrate that for one or more preparations, the requirements set out in Article 5 of Directive 91/414/EEC for inclusion of the active substance in Annex I to that Directive may be met.
3. When requested by the rapporteur Member State as provided for in Article 20(2) to circulate the updated summary dossier or where relevant the updated complete dossier or parts thereof the notifier shall do this at the latest one month from the date of receipt of such a request.
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
1. Where the dossier concerns an active substance listed in Part A of Annex I, in addition to the information required under Article 5 and Article 6(2), the notifier shall submit the following information concerning the active substance and the plant protection product (where applicable):
(a)
all available information on possible risks to human and animal health and the environment including that available from searching the literature and identifying the data bases searched and search terms used;
(b)
available assessment reports from any OECD country;
(c)
for any ongoing tests and studies not yet fully completed, information on those tests and studies and a projected date of completion.
2. The dossier shall physically contain the individual test and study reports containing all the information referred to in paragraph 1.
3. Each Member State shall specify the number of copies of the dossier to be submitted by the notifier when it is acting as a rapporteur and when it receives copies under Article 20(2).
The format of the dossier shall take account of the recommendations made in accordance with the procedure referred to in Article 19 of Directive 91/414/EEC.
Article 10
Specific conditions for submissions of dossiers for active substances listed in Parts B to G of Annex I
1. Where the dossier concerns an active substance listed in Part B to G of Annex I, the notifier shall submit a dossier and a summary dossier.
2. The notifier(s) shall include in the summarydossier:
(a)
the information required under Article 5 and Article 6(2) of this Regulation;
(b)
for each point of Annex II (Part A or Part B as appropriate) to Directive 91/414/EEC and for each point of Annex III (Part A or Part B as appropriate) to that Directive, the summaries and results of tests and studies and the name of the person or institute that has carried out those tests and studies;
(c)
a checklist to be filled in by the notifier, demonstrating that the dossier is complete in accordance with Article 18 of this Regulation.
The tests and studies as referred to in paragraph 2(b) of this Article shall be those relevant to the assessment of the criteria referred to in Article 5 of Directive 91/414/EEC for one or more preparations for the uses taking into account the fact that data gaps in the dossier as regards the information required under Annex II of Directive 91/414/EEC, resulting from the proposed limited range of representative uses of the active substance, may lead to restrictions in the inclusion in Annex I of Directive 91/414/EEC.
3. The complete dossier shall physically contain the individual test and study reports concerning all the information referred to in point (b) and the second subparagraph of paragraph 2.
4. Each Member State shall specify the number of copies and the format of the summary and the complete dossiers to be submitted by the notifiers.
In defining the format of the complete and summary dossiers Member States shall take account of the recommendations made in accordance with the procedure referred to in Article 19 of Directive 91/414/EEC.
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
1. Where the notifier does not submit the dossier or any part thereof within the relevant time limit set out in Article 12, the rapporteur Member State shall inform the Commission and the EFSA within two months of the date of expiry of the time limit, giving any justification for the delay provided by the notifiers.
2. On the basis of the information submitted by the rapporteur Member State in accordance with paragraph 1, the Commission shall determine whether the notifier has demonstrated that the delay in the submission of the dossier was caused by force majeure.
In that case, it shall establish a new time limit for the submission of a dossier fulfilling the relevant requirements of Articles 5, 6, 9, and 10 of this Regulation in accordance with the procedure referred to in Article 19 of Directive 91/414/EEC.
3. The Commission shall decide, as provided for in the fourth subparagraph of Article 8(2) of Directive 91/414/EEC, not to include in Annex I to that Directive an active substance for which no dossier has been submitted within the time limit provided for in Article 12 of this Regulation or the second subparagraph of paragraph 2 of this Article. The Decision shall state the reasons for the non-inclusion.
Member States shall withdraw authorisations of plant protection products containing such active substances within the period prescribed in the Decision.
Article 14
Replacement or withdrawal of notifier
1. If a notifier decides to end its participation in the programme of work for an active substance, it shall immediately inform the rapporteur Member State, the Commission, the EFSA and all other notifiers of the active substance concerned of its decision, giving the reasons.
Where a notifier ends its participation or fails to fulfil its obligations under this Regulation, the procedures provided for in Articles 15 to 24 shall be terminated as regards its dossier.
2. If a notifier agrees with another producer that the notifier shall be replaced for the purposes of further participation in the programme of work under this Regulation, the notifier and such other producer shall inform the rapporteur Member State, the Commission and the EFSA by a common declaration agreeing that such other producer shall replace the original notifier in carrying out the notifier’s duties pursuant to the relevant provisions of Articles 4, 5, 6, 9, 10, 12 and 24. They shall ensure that the other notifiers for the substance concerned are informed at the same time.
The other producer in this case shall be jointly liable with the original notifier for any fees remaining payable in relation to the notifier's application under the regime established by Member States pursuant to Article 30.
3. If all notifiers for an active substance end their participation in the programme of work a Member State may choose to act as notifier for the purposes of further participation in the programme of work.
Any Member State wishing to act as a notifier shall inform the rapporteur Member State, the Commission and the EFSA at the latest one month from the date of being informed that all notifiers have decided to end their participation and shall replace the original notifier in carrying out the notifier’s duties pursuant to the relevant provisions of Articles 4, 5, 6, 9, 10, 12 and 24.
4. All information submitted shall remain available to the rapporteur Member States, the Commission and EFSA
CHAPTER IV
EVALUATIONS OF DOSSIERS
Article 15
General Conditions for evaluations of dossiers
1. Without prejudice to Article 18 the rapporteur Member State shall evaluate all dossiers submitted to it.
2. Without prejudice to Article 7 of Directive 91/414/EEC, the rapporteur Member State shall not accept the submission of new studies during the evaluation except as provided for in Article 9 (1)(c) of this Regulation.
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).
3. 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.
4. Notifiers may seek specific advice from the rapporteur Member State.
Article 16
Cooperation between Member States
1. The rapporteur Member States shall cooperate in the evaluation within each group set out in Annex I and shall organise such cooperation in the most effective and efficient way.
2. The rapporteur Member State identified within each group in Annex I as the ‘lead rapporteur’ shall take a lead in organising that cooperation and in organising the provision of advice to notifiers where it concerns matters of general interest to the other Member States concerned.
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
1. The rapporteur Member State shall assess the checklists provided by the notifiers in accordance with Article 10(2)(c).
2. The rapporteur Member State shall at the latest three months from the date of receipt of all dossiers for an active substance report to the Commission on the completeness of the dossiers.
3. 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 Articles 15 and 19, unless the Commission informs the rapporteur Member State, within two months of the date of receipt of the report of the rapporteur Member State on completeness, that it does not consider the dossier to be complete.
4. For those active substances for which a rapporteur Member State or the Commission consider that no dossier is complete within the meaning of Articles 5, 6 and 10, the Commission shall, within three months from the date of the receipt of the report of the rapporteur Member State on completeness, refer such a report to the Standing Committee for the Food Chain and Animal Health.
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.
5. The Commission shall decide, as provided for in the fourth subparagraph of Article 8 (2) of Directive 91/414/EEC, not to include in Annex I to Directive 91/414/EEC an active substance for which no complete dossier has been submitted within the time limit provided for in Article 12 of this Regulation or the second sub-paragraph of Article 13 (2).
Article 19
Specific conditions for evaluations of dossiers for substances listed in Parts B to G of Annex I
1. Where active substances listed in Part D of Annex I to this Regulation have been evaluated under Directive 98/8/EC those evaluations shall be taken into account, where relevant, for the purposes of this Regulation
2. Where active substances have been evaluated under a former stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC those evaluations shall be taken into account, where relevant, for the purposes of this Regulation.
3. The rapporteur Member State shall evaluate and report only on those active substances for which at least one dossier has been determined to be complete in accordance with Articles 5, 6, and 10. For dossiers concerning the same active substance not determined to be complete, it shall check whether the identity and impurities of the active substance in those dossiers are comparable to the identity and impurities of the active substance in the dossiers considered complete. It shall record its views on this point in the draft assessment report.
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
1. The draft assessment report shall be submitted as far as possible in the format recommended in accordance with the procedure referred to in Article 19 of Directive 91/414/EEC.
2. 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. 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
1. The rapporteur Member State shall send the draft assessment report to the EFSA as quickly as possible, and 12 months from the date of expiry of the time limit provided for in Article 12(a) at the latest.
2. The rapporteur Member State shall include in the draft assessment report a reference to each test or study concerning 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 relied on for the assessment.
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.
3. 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.
4. In addition to the conditions for inclusion proposed under paragraph 2(a) of this Article, the rapporteur Member State may indicate if it has identified, for the proposed limited range of representative uses mentioned in the dossier, any information missing from the dossier which may be required by Member States as confirmatory information when they come to grant authorisations under Article 4 of Directive 91/414/EEC for plant protection products containing that active substance.
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
1. The rapporteur Member State shall send a draft assessment report to the EFSA as quickly as possible, and at the latest 12 months from the date the dossier was determined to be complete in accordance with Article 18(2).
2. The rapporteur Member State shall include in the draft assessment report a reference to each test or study concerning 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 relied on for the assessment.
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.
3. 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
1. A rapporteur Member State shall inform the Commission and the EFSA as soon as it becomes clear that it will be unable to comply with the time limits set out in Articles 21(1) and 22(1) for the submission of the draft assessment report to the EFSA and give the reasons for the delay.
2. 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.
3. Where it has been decided to replace a rapporteur Member State the original rapporteur Member State shall immediately after such a decision has been taken 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 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
Evaluation by the EFSA
1. The EFSA shall, within 30 days of the date of receipt of the draft assessment report as provided for in Article 21(1) or Article 22(1) of this Regulation, check that it clearly complies with the format recommended in accordance with the procedure referred to in Article 19 of Directive 91/414/EEC.
In exceptional cases where the draft assessment report clearly does not fulfil those requirements the Commission shall agree with the EFSA and the rapporteur Member State on a period for resubmission of an amended report which shall not exceed three months.
2. The EFSA shall circulate the draft assessment report to the other Member States and to the Commission and may organise a consultation of experts including the rapporteur Member State.
3. The EFSA may consult some or all of the notifiers of active substances referred to in Annex I on the draft assessment report or parts thereof on the relevant active substances.
4. Without prejudice to Article 7 of Directive 91/414/EEC, submission of new studies shall not be accepted by the EFSA after receipt of the draft assessment report referred to in paragraph 1 of this Article.
However, the rapporteur Member State, with the agreement of the EFSA, may request the notifiers to submit within specified time limits further data considered by the rapporteur Member State or the EFSA necessary to clarify the dossier.
5. 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 of the possible inclusion of the active substance in Annex I to Directive 91/414/EEC, as finalised by the EFSA.
6. The EFSA shall evaluate the draft assessment report and submit its evaluation to the Commission on whether the active substance may be expected to meet the requirements of Article 5(1) of Directive 91/414/EEC at the latest one year from the date on which it has received both the dossier from the notifier, under Article 15(3) of this Regulation, and also the draft assessment report checked for compliance in accordance with paragraph 1 of this Article.
Where appropriate, the EFSA shall give its evaluation of the available options claimed to meet the requirements of Article 5(1) of Directive 91/414/EEC and any data requirements identified.
The Commission and the EFSA shall agree on a schedule for the submission of the evaluation in order to facilitate the planning of the work. The Commission and the EFSA shall also agree on the format of the evaluation.
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
1. The Commission shall present a draft review report at the latest four months from the date of receipt of the EFSA evaluation provided for in Article 24(6)
2. Without prejudice to any proposal it may submit with a view to amending the Annex to Directive 79/117/EEC, and on the basis of the finalised review report provided for in Article 26 of this Regulation, the Commission shall present to the Standing Committee on the Food Chain and Animal Health:
(a)
a draft Directive to include the active substance in Annex I to Directive 91/414/EEC stating where appropriate the conditions for inclusion; such conditions may include the time limit for such inclusion; or
(b)
a draft Decision addressed to the Member States pursuant to the fourth subparagraph of Article 8(2) of Directive 91/414/EEC, not to include that active substance in Annex I to Directive 91/414/EEC, stating the reasons for the non-inclusion and requiring the Member States to withdraw the authorisations of plant protection products containing the active substance.
The Directive or Decision shall be adopted in accordance with the procedure referred to in Article 19 of Directive 91/414/EEC.
3. In addition to the conditions for inclusion proposed under paragraph 2(a), the Commission may indicate if it has identified any information missing from the dossier which may be required by Member States when they come to grant authorisations under Article 4 of Directive 91/414/EEC.
Article 26
Finalised review report
The conclusions of the Standing Committee on the Food Chain and Animal Health, 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 publicly available.
CHAPTER VI
SUSPENSION OF TIME LIMITS, MEASURES TO BE TAKEN BY MEMBER STATES AND INTERIM PROGRESS REPORTS
Article 27
Suspension of time limits
Where, in respect of an active substance listed in Annex I to this Regulation, the Commission presents a proposal for a total prohibition by way of a draft Council act based on Article 6(3) of Directive 79/117/EEC, the time limits provided for in this Regulation shall be suspended while the Council considers that proposal.
Where the Council adopts an amendment to the Annex to Directive 79/117/EEC requiring the total prohibition of that active substance, the procedure under this Regulation shall be terminated for that active substance.
Article 28
Measures taken by Member States
Any Member State which, on the basis of information contained in the dossiers referred to in Articles 5 to 10 or in the draft assessment report concerning an active substance referred to in Articles 19 to 22, intends taking action to withdraw that active substance from the market or to restrict severely the use of a plant protection product containing that active substance, shall, as soon as possible, inform the Commission, the EFSA, the other Member States and the notifiers giving the reasons for its intended action.
Article 29
Interim progress report
All Member States shall submit 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 submitted by:
(a)
30 November 2005 for the active substances listed in Part A of Annex I;
(b)
30 November 2006 for the active substances listed in Parts B to G of Annex I.
CHAPTER VII
FEES AND OTHER CHARGES
Article 30
Fees
1. For active substances listed in Annex I Member States may establish a regime obliging the notifiers to pay a fee or charge for the administrative treatment and the evaluation of dossiers.
The income from such fees or charges shall be used to finance exclusively those costs actually incurred by the rapporteur Member State or to finance general activities of the Member States resulting from their obligations under Articles 15 to 24.
2. Member States shall establish the amount of the fee or charge referred to in paragraph 1 in a transparent manner so that it does not exceed the real cost of the examination and administrative treatment of a dossier or the general activities of the Member States resulting from their obligations under Articles 15 to 24.
However, Member States may provide for a scale of fixed charges based on average costs for the calculation of the total fee.
3. The fee or charge shall be paid in accordance with the procedure to be established by the authorities in each Member State as listed in Annex IV.
Article 31
Other charges, taxes, levies or fees
Article 30 shall be without prejudice to Member States' rights to maintain or introduce, to the extent permitted under Community law, 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 or charge provided for in that Article.
CHAPTER VIII
TEMPORARY AND FINAL PROVISIONS
Article 32
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 33
Entry into force
This Regulation shall enter into force on the seventh day following its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 3 December 2004.