Commission Regulation (EC) No 2229/2004 of 3 December 2004 laying down further detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EECText with EEA relevance
Commission Regulation (EC) No 2229/2004 of 3 December 2004 laying down further detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EECText with EEA relevance
Regulation (EC) No 2229/2004 · Regulation · 38 articles
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
CHAPTER I — SUBJECT MATTER AND SCOPE, DEFINITIONS AND THE DESIGNATED MEMBER STATE AUTHORITY
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.
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.
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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.
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.
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).
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.
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.
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.
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.
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.
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
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.
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
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.
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.
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.
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 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.
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.
ANNEX III
Co-ordinating authority in the Member States (more details are available at the following webside: http://www.europa.eu.int/comm/food/fs/ph_ps/pro/index_en.htm)
AUSTRIA
Bundesamt für Ernährungssicherheit
Landwirtschaftliche Untersuchungen und Forschung Wien
Spargelfeldstraße 191
A-1220 Wien
BELGIUM
Service public fédéral Santé publique, Sécurité de la Chaîne alimentaire et Alimentation
Direction-générale Animaux, Végétaux et Alimentation
Centre administratif de l'État, bâtiment Arcades
B-1010 Bruxelles
CYPRUS
Ministry of Agriculture,
Natural resources and Environment
Department of Agriculture
Loukis Akritas Ave.
1412 Lefkosia
CZECH REPUBLIC
State Phytosanitary Administration,
PPP Division
Zemědělská 1A
61300 Brno
DENMARK
Ministry of Environment and Energy
Danish Environmental Protection Agency
Pesticide Division
Strandgade 29
DK-1401 Copenhagen K
ESTONIA
Estonian Plant Production Inspectorate
Plant Protection Department
Teaduse 2
75501 Saku
Harju Country
Estonia
FINLAND
Plant Production Inspection Centre
Pesticide Division
P.O. BOX 42
FI-00501 Helsinki
FRANCE
Ministère de l’agriculture, de l’alimentation, de la pêche et des affaires rurales
Sous direction de la qualité et de la protection des végétaux
Bureau de la réglementation et de la mise sur le marché des intrans
251, rue de Vaugirard
F-75732 Paris Cedex 15
GERMANY
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL)
Abteilung 2, Pflanzenschutzmittel
Dienststelle Braunschweig
Messeweg 11—12
D-38104 Braunschweig
GREECE
Hellenic Republic
Ministry of Agriculture
General Directorate of Plant Produce
Directorate of Plant Produce Protection
Department of Pesticides
3-4 Hippokratous Street
GR-10164 Athens
HUNGARY
Central Service for Plant Protection and Soil conservation
Budaörsi út 141–145.
1118 Budapest
IRELAND
Pesticide Control Service
Department of Agriculture and Food
Abbotstown Laboratory Complex
Abbotstown, Castleknock
IRL-Dublin 15
ITALY
Ministero della Salute
Direzione Generale della Sanità Pubblica Veterinaria, degli Alimenti e della Nutrizione
Piazza G. Marconi, 25
I-00144 Roma
LATVIA
State Plant Protection Service
Plant Protection Department
Republikas laukums 2,
Riga, LV-1981
Latvia
LITHUANIA
State Plant Protection Service
Kalvarijų 62
09304 Vilnius
Lithuania
LUXEMBOURG
Administration des Services Techniques de l’Agriculture
Service de la protection des Végétaux
Boîte postale 1904
16, route d’Esch
L-1019 Luxembourg
MALTA
Ministry for rural Affairs & The Environment
Plant Health Department
Plant Biotechnology Centre
Annibale Preca Street
NETHERLANDS
College voor de Toelating van Bestrijdingsmiddelen
PO Box 217
NL-6700 AE Wageningen
POLAND
Ministerstwo Rolnictwa i Rozwoju Wsi
Departament Hodowli i Ochrony Roślin
ul. Wspólna 30
00-930 Warszawa
PORTUGAL
Direcção-Geral de Protecção das Culturas,
Quinta do Marquês
P-2780 Oeiras
SLOVAK REPUBLIC
Ministry of Agriculture of the Slovak Republic,
Plant Commodities Department
Dobrovičova 12
81266 Bratislava
SLOVENIA
Ministry of Agriculture, Forestry and Food,
Phytosanitary Administration Republic of Slovenia
6 Einspielerjeva,
SI-1000 Ljubljana
SPAIN
Ministerio de Agricultura, Pesca y Alimentación
Dirección General de Agricultura
Subdirección General de Medios de Producción Agrícolas
Avda. Alfonso XII, 62
E-28014 Madrid
SWEDEN
The Swedish Chemicals Inspectorate, KemI
P.O. Box 2
SE-172 13 Sundbyberg
UNITED KINGDOM
Pesticides Safety Directorate
Department for Environment, Food and Rural Affairs
Mallard House,
Kings Pool,
3 Peasholme Green,
York, YO1 7PX
ANNEX IV
Organisations in the Member States to be contacted concerning further details on the payment of the fees referred to in Article 30 and to which such fees have to be paid
AUSTRIA
Bundesamt für Ernährungssicherheit
Landwirtschaftliche Untersuchungen und Forschung Wien
Spargelfeldstraße 191
A-1220 Wien
BELGIUM
Fonds budgétaire des matières premières et des produits
Service public fédéral Santé publique, Sécurité de la Chaîne alimentaire et Alimentation
Direction-générale Animaux, Végétaux et Alimentation
Centre administratif de l'État, bâtiment Arcades
B-1010 Bruxelles
CYPRUS
Ministry of Agriculture,
Natural resources and Environment
Department of Agriculture
Loukis Akritas Ave.
1412 Lefkosia
CZECH REPUBLIC
State Phytosanitary Administration,
PPP Division
Zemědělská 1A
61300 Brno
DENMARK
Ministry of Environment and Energy
Danish Environmental Protection Agency
Strandgade 29
DK-1401 Copenhagen K
ESTONIA
Estonian Plant Production Inspectorate
Plant Protection Department
Teaduse 2
75501 Saku
Harju Country
Estonia
FINLAND
Plant Production Inspection Centre
Pesticide Division
PO BOX 42
FI-00501 Helsinki
Bank and account:
Nordea Bank
Account: 166030-101330
IBAN: FI3716603000101330
SWIFT: NDEAFIHH
FI-00501 Helsinki
FRANCE
Ministère de l’Agriculture et de la Pêche
Bureau de la Réglementation des Produits antiparasitaires — 251 rue de Vaugirard
F-75732 Paris Cedex 15
GERMANY
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL)
Abteilung 2, Pflanzenschutzmittel
Dienststelle Braunschweig
Messeweg 11—12
D-38104 Braunschweig
GREECE
Hellenic Republic
Ministry of Agriculture
General Directorate of Plant Produce
Directorate of Plant Produce Protection
Department of Pesticides
3-4 Hippokratous Street
GR-10164 Athens
HUNGARY
Central Service for Plant Protection and Soil conservation
Budaörsi út 141–145.
1118 Budapest
IRELAND
Pesticide Control Service
Department of Agriculture, Food and Rural Development
Abbotstown Laboratory Complex
Abbotstown, Castleknock
IRL-Dublin 15
ITALY
Tesoreria Provinciale dello Stato di Viterbo
N. di conto corrente postale n. 52744570
IBAN: IT 43
CIN: E
BIC: BPPIITRRXXX
ABI: 7601
CAB: 14500
LATVIA
State Plant Protection Service
Plant Protection Department
Republikas laukums 2,
Riga, LV-1981
Latvia
LITHUANIA
State Plant Protection Service
Kalvarijų 62
09304 Vilnius
Lithuania
LUXEMBOURG
Administration des Services Techniques de l’Agriculture
Boîte postale 1904
L-1019 Luxembourg
MALTA
Ministry for rural Affairs & The Environment
Plant Health Department
Plant Biotechnology Centre
Annibale Preca Street
THE NETHERLANDS
College voor de Toelating van Bestrijdingsmiddelen
PO Box 217
NL-6700 AE Wageningen
POLAND
Ministerstwo Rolnictwa i Rozwoju Wsi
Departament Hodowli i Ochrony Roślin
ul. Wspólna 30
00-930 Warszawa
PORTUGAL
Direcção-Geral de Protecção das Culturas,
Quinta do Marquês,
P-2780 OEIRAS
Número de conta: 003505840003800793097
Banco: Caixa Geral de Depósitos
SLOVAK REPUBLIC
Ministry of Agriculture of the Slovak Republic,
Plant Commodities Department
Dobrovičova 12
81266 Bratislava
SLOVENIA
Ministry of Agriculture, Forestry and Food,
Phytosanitary Administration Republic of Slovenia
6 Einspielerjeva,
SI-1000 Ljubljana
SPAIN
Ministerio de Agricultura, Pesca y Alimentación
Dirección General de Agricultura
Subdirección General de Medios de Producción Agrícolas
Avda. Alfonso XII, 62
E-28014 Madrid
SWEDEN
The Swedish Chemicals Inspectorate, KemI
P.O. Box 2
SE-172 13 Sundbyberg
National Giro Account: 4465054 – 7
UNITED KINGDOM
Pesticides Safety Directorate
Department for Environment, Food and Rural Affairs
Mallard House,
Kings Pool,
3 Peasholme Green,
York, YO1 7PX
ANNEX V
Details to be notified by producers in new Member States
The notification must be made on paper and by e-mail.
The notification shall contain the following information:
1.
IDENTIFICATION DATA ON THE NOTIFIER
1.1.
Manufacturer of the active substance as defined in point (b) of Article 2 of Regulation (EC) No 1112/2002 (name, address, including location of plant):
1.2.
Name and address of the producer as defined in point (a) of Article 2 of Regulation (EC) No 1112/2002 including the name of the (natural) person responsible for the notification and further engagements resulting from this Regulation.
1.2.1.
(a)
Telephone No
(b)
Telefax No
(c)
E-Mail Address
1.2.2.
(a)
Contact:
(b)
Alternative:
2.
INFORMATION TO FACILITATE IDENTIFICATION
2.1.
Common name (proposed or ISO-accepted where appropriate) specifying, where relevant, any variants thereof such as salts, esters or amines produced by the manufacturer. For micro-organisms the species, and where relevant, subspecies name
2.2.
Chemical name (IUPAC and CAS nomenclature) (where appropriate).
2.3.
CAS, CIPAC and EEC numbers (if available).
2.4.
Empirical and structural formula, molecular mass (where appropriate).
2.5.
Any other information considered necessary to facilitate identification, for example method of manufacture/extraction or origin of materials from which the substance is manufactured.
2.6.
Specification of purity of the active substance in g/kg or g/l (as appropriate).
3.
FURTHER INFORMATION
3.1.
For each Member State a list of crops/uses for which plant protection products containing the active substance are currently authorised or used.
4.
UNDERTAKING
The notifier undertakes to submit to the designated coordinating authority of the designated rapporteur Member State the dossiers within the time limits provided for in Article 12 of Regulation (EC) No 2229/2004.
The notifier declares that he is aware that he will be charged a fee by Member States at the time of the submission of the full dossier.
The notifier confirms that the above information is honest and correct.
The notifier declares that an authorisation by the manufacturer to act as his sole representative for the purpose of complying with this Regulation is enclosed if necessary.
Signature (of the person competent to act for the manufacturer mentioned under 1.1.)
