2002R1490 — EN — 07.09.2010 — 004.001

This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

►B COMMISSION REGULATION (EC) No 1490/2002 of 14 August 2002 laying down further detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC and amending Regulation (EC) No 451/2000 (Text with EEA relevance) (OJ L 224, 21.8.2002, p.23)

Amended by:









▼B

COMMISSION REGULATION (EC) No 1490/2002

of 14 August 2002

laying down further detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC and amending Regulation (EC) No 451/2000

(Text with EEA relevance)







THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant-protection products on the market ( 1 ), as last amended by Commission Directive 2002/48/EC ( 2 ), and in particular the second subparagraph of Article 8(2) thereof, Whereas: (1) The Commission is to undertake a programme of work for the gradual examination of active substances on the market two years after the date of notification of Directive 91/414/EEC within a period of 12 years. The first stage of this programme was laid down by Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the 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 ( 3 ), as last amended by Regulation (EC) No 2266/2000 ( 4 ). This first stage is ongoing. (2) The second stage of work was laid down by 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 ( 5 ), and is also ongoing. (3) A third stage of work was provided for in Regulation (EC) No 451/2000 for an additional number of active substances not covered by the first and second stages of the programme. Producers wishing to secure the inclusion of these active substances in Annex I to Directive 91/414/EEC have provided detailed information relating to the current stage of completeness of their dossiers and on the endpoints and have undertaken to provide a full data package. (4) For the third stage of the work programme, Article 10(3) of Regulation (EC) No 451/2000 specifies that detailed provisions concerning the submission of complete dossiers, the time limit(s) for their submission and the fee regime for the active substances concerned have to be established by the Commission in a Regulation to be adopted in accordance with the second subparagraph of Article 8(2) of Directive 91/414/EEC. (5) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 ( 6 ) 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, and the scope of this involvement should be defined as soon as possible. (6) In order to ensure that dossiers are received by the Member States in a manageable way, the active substances to be evaluated should be divided into two groups with separate time limits for the submission of dossiers. (7) Further, at an initial stage it should be sufficient that notifiers provide only a list of the available tests and studies to the rapporteur Member States, in order to permit the Member States to establish whether a full data package is available to be submitted by the specified time limit. Where such data will not be available by the time limit, it will not be possible to complete re-evaluation of the active substance within the timetable provided for in Directive 91/414/EEC and a decision should therefore be taken immediately not to include the substance concerned in Annex I to the Directive. Authorisation of products containing such active substance should be withdrawn by Member States. (8) The relationships between producers, Member States, the Commission and the EFSA and the obligations on each of them for the implementation of the programme should be laid down, taking into account experience gained during the first and second stages of the programme. Close cooperation between all parties involved and a scrupulous respect of time limits laid down is necessary to ensure the efficiency of the programme. Strict time limits for all elements of the third stage of the work programme should be set in order to ensure its finalisation within an acceptable time period. Where cooperation with notifiers ceases it is impossible to continue further evaluation efficiently and therefore the evaluation should be terminated. (9) 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. (10) It is necessary to define the obligations of notifiers with regard to the formats, time periods and recipient authorities for the information to be submitted. (11) 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. The rapporteur Member State should assess the completeness check 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. (12) Member States should send draft reports of their evaluations to the EFSA. The draft reports prepared by the rapporteur Member States should be peer reviewed by the EFSA before they are submitted to the Standing Committee on the Food Chain and Animal Health. (13) In order to avoid duplication of work, and in particular experiments involving vertebrate animals, producers should be encouraged to submit collective dossiers. (14) 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, operators which 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. (15) 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 prohibiting the placing on the market and use of plant-protection products containing certain active substances ( 7 ), as last amended by the Act of Accession of Austria, Finland and Sweden, where information becomes available to the Commission showing that its requirements may be satisfied. (16) The use of anti-microbials from classes, which are or may be used in human or veterinary medicine for the purpose of plant protection should be discouraged. Two of the substances concerned by this Regulation — kasugamycin and streptomycine — fall into this category ( 8 ). Pending eventual decisions on their inclusion in Annex I, their uses should continue to be restricted and only be permitted where essential. For the purpose of their evaluation, information on anti-microbial resistance will be required. (17) This Regulation shall be without prejudice to Community obligations regarding methyl bromide under the Montreal Protocol. (18) In the case of an apparent imbalance in the responsibilities borne by the Member States as rapporteur in the assessment and evaluation, it should be possible to replace the Member State originally designated as rapporteur for a particular active substance by another Member State. (19) 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 in addition to the fee already paid for the evaluation of the notifications pursuant to Article 13 of Regulation (EC) No 451/2000. (20) Regulation (EC) No 451/2000 provided that for the active substances covered by the third stage of the work programme, the time limit for the submission of a full data package was 25 May 2003 at the latest. That Regulation also provided that detailed provisions concerning the submission of complete dossiers would be established at a later stage. In order to organise the work programme efficiently, it is not necessary to submit full data packages shortly before full dossiers have to be submitted. However, to ensure that active substances without full data packages do not remain on the market, a list of available data should be submitted, while the full data packages should be submitted only in exceptional cases and on request. (21) Regulation (EC) No 451/2000 should be amended accordingly. (22) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Whereas: HAS ADOPTED THIS REGULATION:







Article 1

Subject matter and scope

1. This Regulation lays down further detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC with respect to the continued evaluation of the active substances notified under Regulation (EC) No 451/2000.

2. Article 6(2), (3) and (4), second subparagraph, of Directive 91/414/EEC shall not apply to a substance listed in Annex I to this Regulation as long as the procedures provided for in this Regulation with regard to these substances have not been finalised.

3. This Regulation shall apply without prejudice to:

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

(b) reviews by the Commission pursuant to Article 5(5) of Directive 91/414/EEC;

(c) assessments carried out under Directive 79/117/EEC.

Article 2

Definitions

For the purpose of this Regulation, the definitions in Directive 91/414/EEC shall apply.

The following definitions shall also apply:

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

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

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

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

Article 3

Member State authority

1. Member States shall allocate responsibility for the implementation of their obligations under the programme of work referred to in Article 8(2) of Directive 91/414/EEC to an authority or authorities.

2. Each Member State shall designate one national authority, referred to in Annex III, to coordinate and ensure all necessary contacts with notifiers, other Member States, the Commission and the European Food Safety Authority (EFSA) pursuant to this Regulation. Each Member State shall inform 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 of any modifications thereof.

Article 4

Measures in case of imbalances

If, during the assessment and evaluation referred to in Articles 9 and 10, it becomes apparent that there is an imbalance in the responsibilities borne and the work to be done or actually done by the Member States as rapporteurs, it may be decided, in accordance with the procedure provided for in Article 19 of Directive 91/414/EEC, to replace a Member State originally designated as rapporteur for a particular active substance by another Member State.

In such cases the original rapporteur Member State shall inform the notifiers concerned and shall transfer to the newly designated rapporteur Member State all correspondence and information which it has received as rapporteur Member State for the active substance concerned. The original Member State shall return to the notifier the fee referred to in Article 17 except for the part referred to in paragraph 2(d) thereof. The newly designated rapporteur Member State shall then require the notifiers to pay the fee referred to in Article 17 except the part referred to in paragraph 2(d) thereof.

Article 5

Withdrawal or replacement of notifier

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 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 Article 9 or 10 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 Articles 6, 7, 9, 10 or 11. 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 17.

3. All information submitted shall remain available to the rapporteur Member States, the Commission or the EFSA.

Article 6

Submission and checking of data lists

1. By 23 May 2003 at the latest, the notifier(s) shall submit to the relevant rapporteur Member State the data lists for active substances listed in Annex I, and submit a copy to the EFSA.

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

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

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

2. The data lists shall be prepared in the format specified in accordance with the procedure provided for in Article 19 of Directive 91/414/EEC. The full data package, as defined in Article 10(4) of Regulation (EC) No 451/2000, shall be kept available by the notifiers. On written request from the rapporteur Member State or the Commission, the notifier shall provide without delay, the part of the data package or the full data package requested.

3. The rapporteur Member State shall examine the data lists submitted to establish whether they indicate that a full data package is available to be submitted. For those active substances for which a rapporteur Member State considers that no full data package is available to be submitted, the rapporteur Member State shall request the notifier to submit without delay a full data package and check whether it is complete. The rapporteur Member State shall report the results of these checks to the Commission at the latest within three months of receipt of the data lists.

4. For those active substances for which the rapporteur Member State considers that no full data package is available it shall inform the Commission without delay. In accordance with the procedure provided for in Article 19 of Directive 91/414/EEC, it shall be decided whether a full data package is available.

5. Where it is considered that no full data package is available for a particular active substance, the Commission shall decide, as provided for in the fourth subparagraph of Article 8(2) of Directive 91/414/EEC, not to include the active substance concerned in Annex I to Directive 91/414/EEC.

6. Unless the Commission informs the notifier that no full data package is available for a particular active substance, the notifier shall submit the dossiers referred to in Article 7(2) and (3) by the time limits specified in Article 7(1).

Article 7

Submission of dossiers

1. The notifier(s) shall submit to the relevant rapporteur Member State the summary dossier referred to in paragraph 2 and the complete dossier referred to in paragraph 3, by 30 November 2003 at the latest for active substances listed in Annex I, part A, and by 30 November 2004 at the latest for active substances listed in Annex I, part B.

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

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

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

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 10 of Regulation (EC) No 451/2000 and the name of the person designated by the producers concerned as being responsible for the joint dossier and the processing of the dossier in accordance with this Regulation;

(b) a limited range of representative uses of the active substance, in respect of which the data submitted by the notifier in the dossier shall demonstrate that for one or more preparations, the requirements set out in Article 5 of Directive 91/414/EEC for inclusion of the active substance in Annex I to Directive 91/414/EEC, can be met;

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

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

3. The complete dossier shall physically contain the individual test and study reports concerning all the information referred to in paragraph 2(c), or the evidence referred to in paragraph 2(c)(iii) where work is in progress.

4. Each Member State shall define 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 dossier Member States shall take account of the recommendations made in accordance with the procedure provided for in Article 19 of Directive 91/414/EEC.

5. Where the dossiers or any part of them are not sent within the relevant time limit, the rapporteur Member State shall inform the Commission and the EFSA within two months, giving any justification for the delay provided by the notifiers.

6. On the basis of the information transmitted by the rapporteur Member State in accordance with paragraph 5, the Commission shall determine whether the notifier has demonstrated that the delay in submission of the dossier was caused by force majeure. In this case, it shall establish a new time limit for the submission of a dossier fulfilling the requirements of paragraphs 2 and 3 in accordance with the procedure provided for in Article 19 of Directive 91/414/EEC.

7. 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 dossier has been submitted within the established time limit.

Article 8

Submission of information by third parties

Any person wishing to submit information which might contribute to the evaluation, in particular with regard to the potentially dangerous effects of the active substance or its residues on human and animal health and on the environment to the rapporteur Member States shall do so by 30 November 2003 at the latest for substances listed in Annex I, part A, and by 30 November 2004 at the latest for substances listed in Annex I, part B. The rapporteur Member State shall submit any information received to the EFSA.

Article 9

Completeness check of dossiers

1. For each active substance for which it has been designated rapporteur, the Member State shall examine the dossiers referred to in Article 7(2) and (3) and assess the checklists provided by the notifiers. The rapporteur Member State shall at the latest six months after the receipt of all dossiers for an active substance report to the EFSA and the Commission on the completeness of the dossiers.

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

For those active substances for which one or more dossiers are considered to be complete, the rapporteur Member State shall perform the evaluation as referred to in Article 10, unless the EFSA informs the rapporteur Member State and the Commission, within two months of receipt of the Member State report on completeness, that it does not consider the dossier to be complete.

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

2. For those active substances for which a rapporteur Member State or the EFSA consider that the dossier is not complete within the meaning of Article 7(2) and (3), the Commission shall, within three months after the receipt of the report of the rapporteur Member State or the EFSA, refer such report to the Committee. In accordance with the procedure provided for in Article 19 of Directive 91/414/EEC, it shall be decided whether a dossier is considered complete within the meaning of Article 7(2) and (3).

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 Directive 91/414/EEC an active substance for which no complete dossier has been submitted within the prescribed time limit.

Article 10

Evaluation by the rapporteur Member State

1. 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 Article 9. For such active substances it shall evaluate and report only on the complete dossiers and for the other dossiers it shall check the identity and impurities of the active substance. 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 the provisions of Article 8. It shall send a draft report of its assessment of the dossier to the EFSA as quickly as possible, and at the latest 12 months after the dossier was determined to be complete. The draft assessment report shall be submitted in the format recommended in accordance with the procedure provided for in Article 19 of Directive 91/414/EEC.

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

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

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

The rapporteur Member State shall in particular include in the draft assessment report a reference to each test and study report, for each point of Annex II and Annex III to Directive 91/414/EEC, relied on for the assessment. This reference shall be made in the form of a list of test and study reports including the title, the author(s), the date of the study or test report and the date of publication, the standard to which the test or study was conducted, the holder's name and, if any, the claim made by the holder or notifier for data protection. It shall also mention for the other notified sources of the active substances for which the dossier was considered not to be complete whether it can be concluded that such active substances are comparable within the meaning of Article 13(5) of Directive 91/414/EEC.

2. Without prejudice to Article 7 of Directive 91/414/EEC, submission of new studies shall not be accepted except for the studies as specified in Article 10(4) of Regulation (EC) No 451/2000. The rapporteur Member State may however request the notifiers 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 should be provided; this time limit 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 its examination of the dossier, consult with experts from the EFSA and may request additional technical or scientific information from other Member States to assist the evaluation. The rapporteur Member State may perform the evaluation together with a co-rapporteur Member State.

The rapporteur Member State shall request the notifiers to submit an updated summary dossier to the EFSA, the other Member States and on request to the Commission at the same time as the rapporteur's draft assessment report is sent to the EFSA.

The Member States, the Commission or the EFSA may request through the rapporteur Member State that notifiers also send them an updated complete dossier or parts thereof.

3. As soon as it becomes evident to a rapporteur Member State that it will be unable to comply with the time limit specified in paragraph 1 for the submission of the draft assessment report to the EFSA, it shall inform the Commission and the EFSA and give the reasons for the delay. Where necessary, certain active substances may be reassigned to another Member State in accordance with the procedure provided for in Article 19 of Directive 91/414/EEC.

▼M3

Article 11

Receipt of and access to the draft assessment report

1. After receiving the updated summary dossier and the draft assessment report referred to in Article 10(1) the EFSA shall, within 30 days, acknowledge to the rapporteur Member State receipt of that report.

In exceptional cases where the draft assessment report clearly does not fulfil the requirements concerning the format recommended by the Commission, the Commission shall agree with the EFSA and the rapporteur Member State on a period for resubmission of an amended report. This period shall not exceed two months.

2. The EFSA shall without delay communicate the draft assessment report to the Commission, the other Member States and the notifiers setting a time period of no more than two months for the submission of comments by those Member States and the notifiers.

It shall collate the comments it receives, including available comments from the EFSA, and forward them to the Commission, Member States and the notifiers.

3. The EFSA shall make available at specific request or keep available for consultation by any person the following:

(a) the draft assessment report except the elements thereof which have been accepted as confidential in accordance with Article 14 of Directive 91/414/EEC;

(b) the list of any data required for the evaluation in view of the possible inclusion of the active substance in Annex I to that Directive as finalised by the EFSA where it has finalised such a list.

Article 11a

Examination of the draft assessment report

The Commission shall, without delay, examine the draft assessment report and the recommendation by the rapporteur Member State and the comments received from other Member States, the EFSA and from the notifiers in accordance with Article 11(2).

Article 11b

Active substance with clear indications that they do not have any harmful effects

If there are clear indications that it may be expected that the active substance does not have any harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment, as set out in Annex V, Article 12(1)(a) and (2)(a) shall apply.

Article 11c

Consultation of the EFSA

1. Where Article 11b does not apply, the Commission may, at any time during the evaluation, ask the EFSA to carry out a peer review of the full draft assessment report or to focus on specific points including points related to criteria set out in Annex VI. The EFSA shall organise a consultation of Member States experts including the rapporteur Member State.

Where the Commission requests the EFSA to carry out a full peer review, the EFSA shall deliver its conclusion at the latest six months after the request. Where the Commission does not request a full peer review, but only a conclusion on specific points, the period shall be reduced to three months. The submission of the conclusions shall in any event be no later than 30 September 2008.

2. If during the peer review there are clear indications that an active substance is expected to have harmful effects on human or animal health or on groundwater as set out in Annex VI, the EFSA shall inform the Commission.

The Commission may take a Decision as referred to in Article 11f.

3. The Commission and the EFSA shall agree on a schedule for the delivery of the conclusions in order to facilitate the planning of the work. The Commission and the EFSA shall agree on the format in which the conclusions of the EFSA are submitted.

Article 11d

Submission of additional information after the draft assessment report has been submitted to the EFSA

1. Without prejudice to Article 7 of Directive 91/414/EEC, submission of new studies shall not be accepted.

2. Where the EFSA considers that additional information from the notifier is necessary to comply with a request made by the Commission under Article 11c, the rapporteur Member State shall request that information. Such requests shall be made explicitly and in writing, setting a time period for submission of one month. They shall not concern the submission of new studies. The rapporteur Member State shall inform the Commission and the EFSA of such requests in writing.

The rapporteur Member State shall, within one month after the receipt of such information, evaluate the information received and send its evaluation to the EFSA.

3. Information submitted by the notifier but which has not been requested, or which has not been submitted before the end of the time period referred to in paragraph 2, shall not be taken into account unless this information has been submitted in accordance with Article 7 of Directive 91/414/EEC.

Where the rapporteur Member State, pursuant to paragraph 1 or to the first subparagraph of this paragraph, refuses to take into account studies or information received from the notifier, it shall inform the Commission and the EFSA and indicate the reasons for such refusal.

Article 11e

Withdrawal by notifier

Where Article 11b does not apply, the notifier may withdraw his support of the inclusion of the active substance in Annex I to Directive 91/414/EEC within two months from receipt of the draft assessment report referred to in Article 11(2).

Article 11f

Active substance for which there are clear indications of harmful effects

If there are clear indications that it may be expected that the active substance has harmful effects on human or animal health or on groundwater as set out in Annex VI, the Commission shall take a Decision on the non-inclusion of the active substance in Annex I to Directive 91/414/EEC, in accordance with Article 12(1)(a) and (2)(b) of this Regulation.

Article 12

Presentation of a draft directive or draft decision

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

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

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

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

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

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

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

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

3. By way of derogation from paragraph 2(b), the latest date for Member States to withdraw authorisations shall be 31 December 2010 in the case referred to in paragraph 1(c) unless the Commission has concluded that the substance meets the criteria of Annex VI, if appropriate after having consulted the EFSA. ►M4 However, the latest date for Member States to withdraw authorisations shall be 31 December 2011 where an application has been submitted in accordance with the accelerated procedure provided for in Articles 14 to 19 of Commission Regulation (EC) No 33/2008 ( 9 ). ◄

Article 12a

View by the EFSA

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

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

▼B

Article 13

Finalised review report

Where the Commission submits a draft directive or a draft decision in accordance with Article 12, it shall at the same time submit the conclusions of the Committee's examination in the format of a finalised review report to be noted in the summary record of the meeting. The finalised review report, excluding any parts which refer to confidential information contained in the dossiers and determined as such in accordance with Article 14 of Directive 91/414/EEC, shall be made available for public consultation.

Article 14

Suspension of time limits

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

Article 15

Measures taken by Member States

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

Article 16

Interim progress report

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

Article 17

Fees

1. Member States shall establish a regime obliging the notifiers to pay a fee or charge for the administrative treatment and the evaluation of dossiers.

2. For this purpose, the Member States shall:

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

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

▼M1

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

▼B

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

Article 18

Other charges, taxes, levies or fees

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

Article 19

Temporary measures

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

Article 20

Amendment to Regulation (EC) No 451/2000

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

1. Article 8 is replaced by the following: ‘Article 8 Evaluation of dossiers by rapporteur Member States and the EFSA 1. 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 Article 6(2) and (3). For such active substances it shall evaluate and report only on the complete dossiers and for the other dossiers it shall check the identity and impurities of the active substance. 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 the provisions of Article 5(4)(d). It shall send a draft report of its assessment of the dossier to the European Food Safety Authority (EFSA) as quickly as possible, and at the latest 12 months after the dossier was determined to be complete. The draft assessment report shall be submitted in the format recommended in accordance with the procedure provided for in Article 19 of the Directive. At the same time, the rapporteur Member State shall make a recommendation to the Commission either: — to include the active substance in Annex I to the Directive, stating the conditions for inclusion, or — not to include the active substance in Annex I to the Directive, stating the reasons for the non-inclusion. The rapporteur Member State shall in particular include in the draft assessment report a reference to each test and study report, for each point of Annex II and Annex III to the Directive, relied on for the assessment. This reference shall be made in the form of a list of test and study reports including the title, the author(s), the date of the study or test report and the date of publication, the standard to which the test or study was conducted, the holder's name and, if any, the claim made by the holder or notifier for data protection. It shall also mention for the other notified sources of the active substances for which the dossier was considered not to be complete whether it can be concluded that such active substances are comparable within the meaning of Article 13(5) of 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. When doing so the rapporteur Member State shall set a time limit within which the information should be provided; this time limit 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 this examination, consult with experts from the EFSA and may request additional technical or scientific information from other Member States to assist the evaluation. The rapporteur Member State may perform the evaluation together with a co-rapporteur Member State. The rapporteur Member State shall request the notifiers to submit an updated summary dossier to the EFSA, the other Member States and on request to the Commission at the same time as the rapporteur's draft assessment report is sent to the EFSA. The Member States, the EFSA or the Commission may request through the rapporteur Member State that notifiers also send them the updated complete dossiers or parts thereof. 3. As soon as it becomes evident to a rapporteur Member State that it will be unable to comply with the time limit specified in paragraph 1 for the submission of the draft assessment report to the EFSA, it shall inform the Commission and the EFSA and give the reasons for the delay. All Member States shall provide to the Commission and the EFSA a report of their progress on the evaluation of the active substances for which they are rapporteur. Such report has to be made by 30 April 2003. 4. After receiving the updated summary dossier and the draft assessment report referred to in paragraph 1, the EFSA shall, within 30 days, acknowledge receipt of the report to the rapporteur Member State. In exceptional cases where the draft assessment report clearly does not fulfil the requirements concerning the format recommended by the Commission, the Commission shall agree with the EFSA and the rapporteur Member State on a period for resubmission of an amended report. This period shall not exceed four months. 5. The EFSA shall circulate the rapporteur's draft assessment report to the Member States and may organise a consultation of experts including the rapporteur Member State. The EFSA may consult some or all of the notifiers of active substances specified in Annex I on the report or parts of the report on the relevant active substance. Without prejudice to Article 7 of the Directive, submission of new studies shall not be accepted. The rapporteur Member State, with the agreement of the EFSA, may request the notifiers to submit within specified periods further data considered by the rapporteur member state of the EFSA necessary to clarify the dossier. 6. The EFSA shall make available at specific request or keep available for consultation by any person the following: (a) the information referred to in the last subparagraph of paragraph 1, except 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 into Annex I to the Directive, first as contained in the rapporteur's report and secondly as finalised by the EFSA; (e) the draft assessment report, except the elements thereof which have been accepted as confidential in accordance with Article 14 of the Directive. 7. The EFSA shall evaluate the rapporteur's draft assessment report and deliver its opinion on whether the active substance can be expected to meet the safety requirements of the Directive to the Commission at the latest one year after receipt of the rapporteur Member State draft assessment report. Where appropriate, the EFSA shall give its opinion on the available options claimed to meet the safety requirements. The Commission and the EFSA shall agree on a schedule for the delivery of the opinions in order to facilitate the planning of the work. The Commission and the EFSA shall agree on the format in which the opinion of the EFSA is submitted. 8. At the latest six months after receipt of the EFSA opinion referred to in paragraph 7, the Commission shall submit the draft review report. 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 it shall submit to the Committee: (a) a draft directive 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 draft decision addressed to the Member States to withdraw 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. The directive or decision shall be adopted in accordance with the procedure provided for in Article 19 of the Directive. 9. Where the Commission submits a draft directive or a draft decision in accordance with paragraph 8, it shall at the same time submit the conclusions of the Committee's examination in the format of a finalised review report to be noted in the summary record of the meeting. The finalised review report, excluding any parts which refer to confidential information contained in the dossiers and determined as such in accordance with Article 14 of the Directive, shall be made available for public consultation.’

2. In Article 10(4), the first sentence is replaced by the following: ‘The time limit for the submission of a list of available studies shall be 23 May 2003. A full data package shall be available on 23 May 2003 at the latest.’

3. In Article 11(2), the second sentence is replaced by the following: ‘Member States shall withdraw by 25 July 2003 authorisations of plant-protection products containing active substances for which no admissible notification has been submitted. Authorisations of plant-protection products containing active substances for which no list of available studies has been submitted or for which no full data package is available shall be withdrawn by the deadline referred to in the Decision on the non-inclusion of the active substance concerned.’

4. In Annex I, part A, in relation to the active substance Tolclofos-methyl ‘The Netherlands’ is replaced by ‘Sweden’.

Article 21

Entry into force

This Regulation shall enter into force on the seventh day following its publication in the Official Journal of the European Communities.

This Regulation shall be binding in its entirety and directly applicable in all Member States.









ANNEX I

List of active substances (column A), rapporteur Member States (column B) and notifying producers (code identification) (column C)

PART A







A B C Name Rapporteur Member State Notifiers Abamectin Netherlands IBE-ES PRO-ES SNO-FR SYN-GB Acetochlor Spain DAS-GB MON-BE RIV-IE Amidosulfuron Austria AVS-DE Benfluralin Belgium DAS-GB MAK-BE Bifenox Belgium FSG-DE Bifenthrin France FMC-BE Bitertanol United Kingdom BAY-DE Bromuconazole Belgium AVS-FR Buprofezin Finland NIH-GB Butralin France CFP-FR Carbetamide France FSG-DE Chlorflurenol Germany SCC-DE Chloridazon Germany BAS-DE Chloropicrin Italy EBR-NL RIV-IE Chlorthal-dimethyl Greece AMV-GB Cinosulfuron Italy SYN-GB Clethodim Netherlands TOM-FR Clofentezine United Kingdom MAK-BE Clomazone Denmark FMC-BE Coppercompounds France EUC-GB Cresylic acid Netherlands ASP-NL Cyanamide Germany DUS-DE Cycloxydim Austria BAS-DE Dichlorophen Ireland CCD-GB Diclofop France AVS-DE PPC-ES Dicloran Spain MAI-PT Diflubenzuron Sweden UNI-NL Diflufenican United Kingdom AVS-DE HRM-BE MAK-BE Dimethipin Greece CRO-GB Dithianon Greece BAS-BE HRM-BE Epoxiconazole Germany BAS-DE MAK-BE Etofenprox Italy LKC-UK Fenazaquin Greece DAS-GB Fenbuconazole United Kingdom DAS-GB Fenoxaprop-P Austria AVS-DE Fenpropidin Sweden SYN-GB Fenpropimorph Germany BAS-DE Fenpyroximate Germany NIH-GB Fluazifop-P France SYN-GB Fluazinam Austria ISK-BE Fludioxonyl Denmark SYN-GB Fluometuron Greece MAK-BE NLI-AT Fluquinconazole Ireland AVS-FR Flurenol Germany SCC-DE Flutolanil Finland NIH-GB Fuberidazole United Kingdom BAY-DE Hexaflumuron Portugal DAS-GB Hexythiazox Finland NPS-DE Imidacloprid Germany BAY-DE Kasugamycin Netherlands LAI-ES Mefluidide Ireland MKC-BE Mepiquat United Kingdom BAS-DE Metaldehyde Austria LON-DE Metazachlor United Kingdom BAS-DE FSG-DE MAK-BE Methyl bromide United Kingdom EBR-NL Myclobutanil Belgium DAS-GB Napropamide Denmark UPL-GB Nicosulfuron United Kingdom ISK-BE Nuarimol Portugal DAS-GB Pencycuron Netherlands BAY-DE Polyoxin Spain LAI-ES Pretilachlor Italy SYN-GB Propaquizafop Italy MAK-BE Prosulfocarb Sweden SYN-GB Pyriproxyfen Netherlands SUM-FR Quinoclamine Sweden AKA-DE Streptomycine Netherlands DSM-NL Tebufenozide Germany DAS-GB ▼M2 ————— ▼B Tetraconazole Italy ISA-IT Thiobencarb Spain KCI-GB Tralkoxydim United Kingdom SYN-GB Triadimefon United Kingdom BAY-DE Triadimenol United Kingdom BAY-DE MAK-BE Tridemorph Germany BAS-DE Triflumizole Netherlands CRE-NL Triflumuron Italy BAY-DE Triflusulfuron France DPD-FR Zeta-Cypermethrin Belgium FMC-BE

PART B







A B C Name Rapporteur Member State Notifiers 8-Hydroxyquinoline Spain ASU-DE PRO-ES Aclonifen Germany AVS-DE Acrinathrin France AVS-DE Aluminium phosphide Germany DET-DE Ammonium sulphamate Ireland DAP-GB Asulam United Kingdom AVS-DE Azocyclotin Italy CRX-FR Bensulfuron Italy DPD-FR Bupirimate Netherlands MAK-BE Calcium phosphide Germany CFW-DE Carboxin United Kingdom CRO-GB Chlorate France ATO-FR Chlormequat United Kingdom BCL-IE CTF-AT FSG-DE PUS-FR Chlorsulfuron Greece DPD-FR Cyhexatin Italy CRX-FR OXO-IT Cymoxanil Austria CAL-FR DPD-FR OXO-IT PUS-FR Cyproconazole Ireland SYN-GB Cyromazine Greece SYN-GB Dazomet Belgium BAS-DE Dicamba Denmark GHA-GB SYN-GB Dichlobenil Netherlands UNI-NL Dichlorobenzoic acid methylester Germany ASU-DE Dicofol Spain DAS-GB MAK-BE Diethofencarb France SUM-FR Difenoconazole Sweden SYN-GB Dimethachlor Germany SYN-GB Diniconazole France SUM-FR Diphenylamine Ireland CRX-FR CSI-UK Dodemorph Netherlands BAS-DE Dodine Portugal CAG-BE OXO-IT Ethalfluralin Greece DAS-GB Etridiazole Netherlands UNI-NL Fenbutatin oxide Belgium BAS-BE CRX-FR Fenoxycarb Netherlands SYN-GB Flamprop-M Sweden BAS-BE Flufenoxuron France BAS-BE Flurochloridone Spain MAK-BE Flurprimidole Finland DAS-GB Flutriafol United Kingdom CHE-DK Guazatine United Kingdom MAK-BE Hexaconazole Italy IQV-ES SYN-GB Hymexazol Finland TSG-GB Imazamethabenz United Kingdom BAS-BE Imazaquin Belgium BAS-BE Imazethapyr Italy BAS-BE Isoxaben Sweden DAS-GB Lenacil Belgium HRM-BE SCH-DE Lufenuron Portugal SYN-GB Magnesium phosphide Germany DET-DE Metam Belgium FMF-ES LAI-ES MAK-BE UCB-BE Metamitron United Kingdom BAY-DE BCL-IE EXC-BE FSG-DE HRM-BE MAK-BE PUS-FR UPL-GB Methabenzthiazuron Sweden PUS-FR Metosulam France BAY-DE Monocarbamide-dihydrogensulphate Spain AGX-GB Oryzalin France DAS-GB Oxadiazon Italy AVS-DE Oxyfluorfen Spain DAS-GB MAK-BE PPC-ES Paclobutrazol United Kingdom SYN-GB Penconazole Germany SYN-GB Picloram United Kingdom DAS-GB Primisulfuron Austria SYN-GB Prochloraz Ireland AVS-FR BCL-IE MAK-BE PUS-FR SPC-FR Propachlor Netherlands MAK-BE MON-BE Propanil Italy DAS-GB MAK-BE RCO-PT Propargite France CRO-GB PPC-ES Pyridaben Netherlands NCI-DE Quinclorac Portugal BAS-DE Quinmerac United Kingdom BAS-DE Quizalofop-P Finland CRO-GB MAK-BE NCI-DE Sintofen France DPD-FR Sodium 5-nitroguaiacolate Greece CAL-FR Sodium o-nitrophenolate Greece CAL-FR Sodium p-nitrophenolate Greece CAL-FR Sodium tetrathiocarbonate Spain AGX-GB Sulcotrione Germany BAY-DE Tau-fluvalinate Denmark MAK-BE Tebuconazole Denmark BAY-DE MAK-BE Tebufenpyrad Germany BAS-BE ▼M2 Teflubenzuron United Kingdom BAS-BE ▼B Tefluthrin Germany SYN-GB Terbuthylazine United Kingdom MAK-BE OXO-IT SYN-GB Thidiazuron Spain AVS-FR Tri-allate United Kingdom MON-BE Triazoxide United Kingdom BAY-DE Tricyclazole France DAS-GB









ANNEX II

List of notifiers' code identification, names and addresses







Code identification Name Address AGX-GB Agrilex UK Ltd PO Box 31RobertsbridgeTN32 5ZLUnited KingdomTel. (44-1580) 88 20 59Fax (44-1580) 88 20 57 AKA-DE Agro-Kanesho Co., Ltd, European Branch Stader ElbstraßeD-21683 StadeTel. (49-41) 41 40 83 88Fax (49-41) 41 40 83 90 AMV-GB Amvac Chemical UK Ltd Surrey Technology Centre,40 Occam RdThe Surrey Research ParkGuildford,Surrey GU2 5YGUnited KingdomTel. (44-1483) 29 57 80Fax (44-1483) 29 57 81 ASP-NL Asepta BV Cyclotronweg 1 / P.O. Box 332600 AA DelftNederlandTel. (31-15) 256 92 10Fax (31-15) 257 19 01 ASU-DE Stähler Agrochemie GmbH & Co. KG Postfach 2047D-21680 StadeTel. (49-41) 41 92 04-0Fax (49-41) 41 92 04-10 ATO-FR Atofina 4-8, cours MicheletF-92800 PuteauxTel. (33-1) 49 00 80 80Fax (33-1) 49 00 88 80 AVS-DE Aventis CropScience GmbH Industriepark HöchstGebäude K 607D-65926 Frankfurt am MainTel. (49-69) 305 66 99Fax (49-69) 305 176 69 AVS-FR Aventis CropScience SA 14-20, rue Pierre BaizetBP 9163F-69263 Lyon Cedex 09Tel. (33-4) 72 85 25 25Fax (33-4) 72 85 30 81 BAS-BE BASF (Belgium) Global Regulatory Affairs — APD/RFAvenue Hamoir, 14B-1180 BruxellesTel. (32-2) 373 27 11Fax (32-2) 373 27 00 BAS-DE BASF AG (Deutschland) Agricultural CenterPO Box 120D-67114 LimburgerhofTel. (49-621) 60-0Fax (49-621) 60-27701 BAY-DE Bayer AG Business Group Crop ProtectionAgricultural Centre MonheimD-51368 LeverkusenTel. (49-2173) 38 49 28Fax (49-2173) 38 37 35 BCL-IE Barclay Chemicals Ltd Tyrellstown WayDamastown Industrial ParkMulhuddartDublin 15IrelandTel. (353-18) 42 57 55Fax (353-18) 42 53 81 CAG-BE Chimac-Agriphar SA 26, rue de RenoryB-4102 OugréeTel. (32-4) 385 97 46Fax (32-4) 385 97 49 CAL-FR Calliope SAS Route d'ArtixBP 80F-64150 NoguèresTel. (33-5) 59 60 92 92Fax (33-5) 59 60 92 19 CCD-GB Coalite Chemicals Division PO Box 152Buttermilk LaneBolsoverChesterfieldDerbyshire S44 6AZUnited KingdomTel. (44-1246) 82 68 16Fax (44-1246) 24 03 09 CFP-FR CFPI Nufarm Regulatory Affairs Dept.28, boulevard CamélinatF-92230 GennevilliersTel. (33-1) 40 85 50 20Fax (33-1) 40 85 51 56 CFW-DE Chemische Fabrik Wülfel GmbH & Co. KG Hildesheimer Straße 305D-30519 HannoverTel. (49-511) 98 49 60Fax (49-511) 984 96 40 CHE-DK Cheminova A/S Thyborønvej 76-78DK-7673 HarboøreTel. (45) 96 90 96 90Fax (45) 96 90 96 91 CRE-NL Certis Europe BV Straatweg 30BPO Box 11803600 BD MaarssenNederlandTel. (31-346) 55 24 00Fax (31-346) 55 42 74 CRO-GB Crompton Europe Ltd Registration DepartmentKennet House4 Langley QuaySloughBerkshireSL3 6EHUnited KingdomTel. (44-17) 53 60 30 00Fax (44-17) 53 60 30 77 CRX-FR Cerexagri Registration Department1, rue des Frères LumièreF-78370 PlaisirTel. (33-1) 30 81 73 00Fax (33-1) 30 81 72 51 CSI-UK CSI-Europe Pentlands Science ParkPenicuikEdinburghEH26 0PZUnited KingdomTel. (44-131) 445 60 82Fax (44-131) 445 60 85 CTF-AT CCC Task Force c/o Nufarm GmbH & Co KGSt.-Peter-Straße 25A-4021 LinzTel. (43-732) 69 18 23 13Fax (43-732) 69 18 20 04 DAP-GB Dax Products Ltd 76 Cyprus RoadNottinghamNG3 5EDUnited KingdomTel. (44-11) 59 26 9996Fax (44-11) 59 66 1173 DAS-GB Dow AgroSciences Letcombe LaboratoryLetcombe RegisWantageOxonOX12 9JTUnited KingdomTel. (49-69) 78 99 60Fax (49-69) 97 84 24 77 DET-DE Detia Freyberg GmbH Dr.-Werner-Freyberg-Straße 11D-69514 LaudenbachTel. (49-6201) 70 80Fax (49-6201) 70 84 27 DPD-FR DuPont de Nemours (France) SAS Crop Protection Products137, rue de l'UniversitéF-75334 Paris Cedex 07Tel. (33-1) 45 50 65 50Fax (33-1) 45 50 60 05 DSM-NL DSM Food Specialties, Agri Ingredients Alexander Fleminglaan 1PO Box 12600 MA DelftNederlandTel. (31-15) 279 91 11Fax (31-15) 279 34 82 DUS-DE Degussa AG Dr.-Albert-Frank-Straße 32D-83308 TrostbergTel. (49-8621) 86-0Fax (49-8621) 86 22 52 EBR-NL Eurobrom BV Regulatory Affairs DepartmentVerrijn Stuartlaan 1c2288 EK RijswijkNederlandTel. (31-70) 3 408 408Fax (31-70) 3 999 035 EUC-GB European Union Copper Task Force c/o TSGEConyngham HallKnaresboroughNorth YorkshireHG5 9AYUnited KingdomTel. (44-1423) 79 91 51Fax (44-1423) 79 91 55 EXC-BE Excel Industries Ltd Luithagen Haven 9B-2030 AntwerpenTel. (32-3) 239 82 24Fax (32-3) 239 82 69 FMC-BE FMC Chemical SPRL Agricultural Products GroupBoulevard de la Plaine 9/3B-1050 BruxellesTel. (32-2) 645 95 84Fax (32-2) 645 96 55 FMF-ES FMC Foret SA Córcega 293E-08008 BarcelonaTel. (34) 934 16 75 17Fax (34) 934 16 74 13 FSG-DE Feinchemie Schwebda GmbH Straßburger Straße 5D-37269 EschwegeTel. (49-221) 94 98 14-0Fax (49-221) 94 98 14 15 GHA-GB Gharda Chemicals Ltd Europe Holbrook House72 Lower Addiscombe RoadCroydonCR9 6ADUnited KingdomTel. (44-2086) 55 41 03Fax (44-2086) 55 41 02 HRM-BE Hermoo Belgium NV Zepperenweg 257B-3800 Sint-TruidenTel. (32-11) 68 68 66Fax (32-11) 70 74 84 IBE-ES Iberotam SA Muntaner, 322, 12aE-08021 BarcelonaTel. (34) 934 54 34 64Fax (34) 934 54 89 21 IQV-ES Industrias Químicas del Vallés SA Av. Rafael Casanova 81E-08100 Mollet del Vallès ( Barcelona)Tel. (34) 935 79 66 77Fax (34) 935 93 80 11 ISA-IT Isagro SPA Registration DepartmentCentro Uffici San Siro Fabbricato D ala 3 Via Caldera, 21I-20153 MilanoTel. (39-02) 40 90 11Fax (39-02) 40 90 12 87 ISK-BE ISK Biosciences Europe SA Tour ITTAvenue Louise 480 bte 12B-1050 BruxellesTel. (32-2) 627 86 11Fax (32-2) 627 86 00 KCI-GB Kumiai Chemical Industry Co., Ltd London Liaison Office35 PiccadillyLondonW1J 0DWUnited KingdomTel. (44-2077) 34 72 82Fax (44-2077) 34 45 61 LAI-ES Lainco, SA Polígono Can JardíAv. Bizet 8-12E-08191 Rubí ( Barcelona)Tel. (34) 935 86 20 15Fax (34) 935 86 20 16 LKC-UK Landis Kane Consulting PO Box 383CheltenhamGloucestershireGL52 6WDUnited KingdomTel. (44-4161) 906 85 04Fax (44-4161) 906 85 09 LON-DE Lonza GmbH Morianstraße 32Postfach 13 14 53D-42041 WuppertalTel. (49-202) 245 38-0Fax (49-202) 245 38 10 MAI-PT Margarita Internacional Comércio e Serviços, LimitadaRua do Bom Jesus, 18-3.o Esq.oP-9050-028 FunchalTel. (351-291) 23 24 84 MAK-BE Makhteshim Agan International Coordination Center (MAICC)Avenue Louise 283B-1050 BruxellesTel. (32-2) 646 86 06Fax (32-2) 646 91 52 MKC-BE McKenna & Cuneo, L.L.P. 56, rue des Colonies, Box 14B-1000 BruxellesTel. (32-2) 278 12 11Fax (32-2) 278 12 00 MON-BE Monsanto Europe SA Regulatory DepartmentAvenue de Tervuren 270-272B-1150 BruxellesTel. (32-10) 49 42 11Fax (32-10) 49 42 42 NCI-DE Nissan Chemical Europe GmbH Deutsch-Japanisches CenterImmermannstraße 45D-40210 DüsseldorfTel. (49-211) 17 22 70Fax (49-211) 16 22 43 NIH-GB Nihon Nohyaku Co., Ltd 8 Cork StreetMayfairLondonW1S 3LJUnited KingdomTel. (44-2074) 34 00 33Fax (44-2072) 87 13 35 NLI-AT Nufarm GmbH & Co KG St.-Peter-Straße 25A-4021 LinzTel. (43-73) 26 91 80Fax (43-73) 26 91 82 004 NPS-DE Nisso Chemical Europe GmbH Berliner Allee 29/Ecke SteinstraßeD-40212 DüsseldorfTel. (49-211) 323 01 35Fax (49-211) 32 82 31 OXO-IT Oxon Italia SpA Via Sempione, 195I-20016 Pero( MI)Tel. (39-02) 35 37 81Fax (39-02) 339 02 75 PPC-ES Proplan-Plant Protection Company, SL Vía de las dos Castillas 11. Bloque 3, 1o C.E-28224 Pozuelo de Alarcón ( Madrid)Tel. (34) 913 52 29 60Fax (34) 913 52 72 82 PRO-ES Probelte, SA Ctra. Madrid Km. 384.6Polígono Industrial El TiroE-30100 Espinardo ( Murcia)Tel. (34) 968 30 72 50Fax (34) 968 30 54 32 PUS-FR Phytorus SA Parc d'Ariane, Bât B11, boulevard de la grande ThumineF-13090 Aix-en-ProvenceTel. (33-1) 60 27 26 26Fax (33-4) 42 52 68 52 RCO-PT Rice Madeira Company Europe Comércio Internacional e Serviços, Sociedade Unipessoal Lda.Rua 31 de Janeiro n.o 81-A, 5.o EPT-9050-011 Funchal ( Madeira)Tel. (351-291) 22 77 44Fax (351-291) 22 66 31 RIV-IE Rivendell Consulting Ltd Rivendell HouseStamullenCounty MeathIrelandTel. (353-18) 41 52 95Fax (353-18) 41 47 68 SCC-DE SCC Scientific Consulting Company GmbH Mikroforum Ring 1D-55234 WendelsheimTel. (49-67) 34 91 90Fax (49-67) 34 91 91 91 SCH-DE Dr. Schirm AG Kipper Straße 9-11D-44147 DortmundTel. (49-392) 845 63 02Fax (49-392) 845 63 00 SNO-FR SINON EU Corporation 170, boulevard HaussmannF-75008 ParisTel. (33-5) 59 60 92 92Fax (33-5) 59 60 92 19 SPC-FR Sipcam-Phyteurop Courcellor 235, rue d'AlsaceF-92531 Levallois-Perret CedexTel. (33-1) 47 59 77 00Fax (33-1) 47 37 54 52 SUM-FR Sumitomo Chemical Agro Europe SA 2, rue Claude ChappeF-69370 Saint-Didier-au-Mont-d'OrTel. (33-4) 78 64 32 60Fax (33-4) 78 47 70 05 SYN-DE Syngenta Agro GmbH Am Technologiepark 1-5Postfach 110353D-63477 MaintalTel. (49-6971) 55-0Fax (49-6971) 55-319 SYN-GB Syngenta Europe Ltd European Regional CentrePriestley RoadSurrey Research ParkGuildfordSurreyGU2 7YHUnited KingdomTel. (44-1483) 26 00 00Fax (44-1483) 26 00 19 TOM-FR Tomen France 18, avenue de l'OpéraF-75001 ParisTel. (33-1) 42 96 14 56Fax (33-1) 42 97 52 91 TSG-GB Sankyo Company Ltd C/o TSGEConyngham HallKnaresboroughNorth YorkshireHG5 9AYUnited KingdomTel. (44-1423) 79 91 51Fax (44-1423) 79 91 55 UCB-BE UCB Chemicals NV Allée de la Recherche 60B-1070 BruxellesTel. (32-2) 559 99 99Fax (32-2) 559 99 00 UNI-NL Uniroyal Chemical Europe BV Registration DepartmentAnkerweg 181041 AT AmsterdamNederlandTel. (31-20) 587 18 60Fax (31-20) 587 18 68 UPL-GB United Phosphorus Ltd Chadwick HouseBirchwood ParkWarringtonCheshireWA3 6AEUnited KingdomTel. (44-1925) 81 99 99Fax (44-1925) 81 74 25









ANNEX III

Coordinating authority in the Member States (more details are available at the following website: http://www.europa.eu.int/comm/food/fs/ph_ps/pro/index_en.htm)

AUSTRIA

Bundesamt für Ernährungssicherheit

Landwirtschaftliche Untersuchungen und Forschung Wein

Spargelfeldstraße 191

A-1220 Wien

BELGIUM

Ministère des classes moyennes et de l'agriculture

Service Qualité des matières premières et analyses

WTC 3, 8e étage

Boulevard S. Bolivar 30

B-1000 Bruxelles

DENMARK

Ministry of Environment and Energy

Danish Environmental Protection Agency

Pesticide Division

Strandgade 29

DK-1401 Copenhagen K

GERMANY

Biologische Bundesanstalt für Land- und Forstwirtschaft (BBA)

Abteilung für Pflanzenschutzmittel und Anwendungstechnik (AP)

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

SPAIN

Ministerio de Agricultura, Pesca y Alimentación

Dirección General de Agricultura

Subdirección General de Medios de Producción Agrícolas

Ciudad de Barcelona, 118-120

E-28007 Madrid

FINLAND

Kasvintuotannon tarkastuskeskus

Torjunta-aineet

PL 42

FIN-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 intrants

251, rue de Vaugirard

F-75732 Paris Cedex 15

IRELAND

Pesticide Control Service

Department of Agriculture and Food

Abbotstown Laboratory Complex

Abbotstown, Castleknock

Dublin 15

Ireland

ITALY

Ministero della Salute

Direzione generale della Sanità pubblica veterinaria degli alimenti e della nutrizione

Piazza G. Marconi, 25

I-00144 Roma

LUXEMBOURG

Administration des services techniques de l'agriculture

Service de la protection des végétaux

Boîte postale 1904

16, route d'Esch

L-1019 Luxembourg

NETHERLANDS

College voor de Toelating van Bestrijdingsmiddelen

Postbus 217

6700 AE Wageningen

Nederland

PORTUGAL

Direcção-Geral de Protecção das Culturas

Quinta do Marquês

P-2780 Oeiras

SWEDEN

Kemikalieinspektionen

Box 1384

S-17127 Solna

UNITED KINGDOM

Pesticides Safety Directorate

Department for Environment, Food and Rural Affairs

Mallard House

Kings Pool

3 Peasholme Green

York YO1 7PX

United Kingdom









ANNEX IV

Organisations in the Member States to be contacted concerning further details on the payment of the fees referred to in Article 17 and to which such fees have to be paid

AUSTRIA

Bundesamt für Ernährungssicherheit

Landwirtschaftliche Untersuchungen und Forschung Wein

Spargelfeldstraße 191

A-1220 Wien

BELGIUM

Fonds budgétaire des matières premières

Ministère des classes moyennes et de l'agriculture

Inspection générale des matières premières et produits transformés, WTC 3

Boulevard S. Bolivar 30

B-1000 Bruxelles

Account number 679-2005985-25 (Banque de la Poste)

DENMARK

Ministry of Environment and Energy

Danish Environmental Protection Agency

Strandgade 29

DK-1401 Copenhagen K

GERMANY

Biologische Bundesanstalt für Land- und Forstwirtschaft

Abteilung für Pflanzenschutzmittel und Anwendungstechnik

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

SPAIN

Ministerio de Agricultura, Pesca y Alimentación

Dirección General de Agricultura

Subdirección General de Medios de Producción Agrícolas

Ciudad de Barcelona, 118-120

E-28007 Madrid

FINLAND

Kasvintuotannon tarkastuskeskus

Torjunta-aineet

PL 42

FIN-00501 Helsinki

Bank and account:

LEONIA BANK PLC

PSP BFIHH

800015-18982

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

IRELAND

Pesticide Control Service

Department of Agriculture, Food and Rural Development

Abbotstown Laboratory Complex

Abbotstown, Castleknock

Dublin 15

Ireland

ITALY

Tesoreria provinciale dello Stato di Viterbo

Post current account number: 11281011

LUXEMBOURG

Administration des services techniques de l'agriculture

Boîte postale 1904

L-1019 Luxembourg

THE NETHERLANDS

College voor de Toelating van Bestrijdingsmiddelen

Postbus 217

6700 AE Wageningen

Nederland

PORTUGAL

Direcção-Geral de Protecção das Culturas

Quinta do Marquês

P-2780 Oeiras

Account number: 003505840003800793097

Bank: Caixa Geral de Depósitos

SWEDEN

Kemikalieinspektionen

Box 1384

S-17127 Solna

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

United Kingdom

▼M3









ANNEX V

Criteria for clear indications of no harmful effects

An active substance shall be considered as fulfilling the requirement, as referred to in Article 11b, of there being clear indications that it may be expected that it does not have any harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment if all the criteria set out in points 1 and 2 are met.

1. The active substance satisfies the following criteria: (a) it is not classified or proposed for classification as C (carcinogenic effects) M (mutagenic effects) R (toxic to reproduction) in categories 1, 2 or 3 in accordance with Directive 67/548/EEC; (b) either not requested or, if required, an ADI (Acceptable Daily Intake), AOEL (Acceptable Operator Exposure Level) and ARfD (Acute Reference Dose) can be established on the basis of the standard assessment factor of 100; (c) it is not considered to have the potential to meet the criteria of a persistent organic pollutant set out in Regulation (EC) No 850/2004 of the European Parliament and of the Council ( 10 ); (d) it is not considered to have the potential to meet the criteria set out in Annex XIII to the Regulation (EC) No 1907/2006 of the European Parliament and of the Council ( 11 ).

2. At least one supported representative use of the active substance satisfies all of the following criteria: (a) operator exposure is less than or equal to 75 % of the AOEL in modelled scenarios, considered relevant for the intended use and where the use of such modelling is appropriate to the supported use and at maximum using gloves as personal protective equipment (PPE); (b) bystander exposure and worker exposure is less than or equal to 75 % AOEL in modelled scenarios, considered relevant for the intended use and where the use of such modelling is appropriate to the supported use and without the use of PPE; (c) consumer exposure is less than or equal to 75 % of the ADI or ARfD (where such a value is necessarily established) in all available EU consumer diets on the basis of the MRLs (Maximum Residues Level) proposed for the active substance (without special refinements); (d) leaching to groundwater is below 0,1 μg/l in at least half of the scenarios considered relevant for the intended use, or in relevant lysimeter/field studies, for both the parent substance and relevant metabolites; (e) buffer zones for the protection of the environment do not exceed 30m without any further risk mitigation measures (e.g. drift reducing nozzles); (f) the risk to non-target organisms is acceptable based on standard refinements.









ANNEX VI

Criteria for clear indications of harmful effects

An active substance shall be considered as fulfilling the requirement, as referred to in Article 11f, of there being clear indications that on the basis on the available data, and which are evaluated in accordance with the provisions of Article 11d, it may be expected that it has harmful effects on human or animal health or on groundwater if either the criterion in point 1 or one of the criteria in point 2 is met.

1. As regards the active substance, the existing evidence is not sufficient to allow the establishment of an ADI, ARfD or an AOEL and such values are necessary to conduct a consumer and operator risk assessment.

2. As regards each supported representative use, at least one of the following criteria is met: (a) operator exposure is greater than 100 % AOEL in all modelled scenarios with the use of PPE/RPE (Personal Protective Equipment/Respiratory Protective Equipment), where the use of such modelling is appropriate to the supported use, and where actual exposure data, if available, also indicate that the AOEL will be exceeded under normal conditions of use; (b) bystander exposure and worker exposure is greater than 100 % AOEL in modelled scenarios, where the use of such modelling is appropriate to the supported use, and where actual exposure data, if available, indicate that the AOEL will be exceeded for these groups under normal conditions of use; (c) consumer exposure is greater than 100 % of the ADI or ARfD (where such a value is required) in at least one of the available EU consumer diets on the basis of the MRLs (Maximum Residues Level) proposed for the active substance; (d) leaching to groundwater is equal to or above 0,1 μg/l in all modelled scenarios either for the parent substance or for relevant metabolites.