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

Type Regulation
Publication 2004-12-24
Last updated 2010-09-07
State In force
Department European Commission
Source EUR-Lex
articles 41
Reform history JSON API

CHAPTER I SUBJECT MATTER AND SCOPE, DEFINITIONS AND THE DESIGNATED MEMBER STATE AUTHORITY

Article 1

Subject matter and scope
1.

This Regulation lays down:

  • (a) further detailed rules for the implementation of the fourth stage of the programme of work referred to in the second subparagraph of Article 8(2) of Directive 91/414/EEC (the programme of work) with respect to the continued evaluation of the active substances notified under Regulation (EC) No 1112/2002;
  • (b) rules covering the active substances that were on the market before 1 May 2004 in the Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and Slovakia and which are not included in stages one to three of the programme of work and which are not covered by Regulation (EC) No 1112/2002.
2.

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

3.

This Regulation shall apply without prejudice to:

  • (a) reviews by Member States of active substances listed in Annex I to this Regulation in particular pursuant to renewals of authorisations in accordance with Article 4(4) of Directive 91/414/EEC;
  • (b) reviews by the Commission in accordance with Article 5(5) of Directive 91/414/EEC;
  • (c) assessments carried out under Directive 79/117/EEC.

Article 2

Definitions

For the purpose of this Regulation, the definitions set out in Article 2 of Directive 91/414/EEC and Article 2 of Regulation (EC) No 1112/2002 shall apply.

The following definitions shall also apply:

  • (a) ‘notifier’ means the natural or legal person who has submitted a notification in accordance with:
  • (i) Regulation (EC) No 1112/2002, as listed in Annex II to this Regulation, or
  • (ii) Article 4 of this Regulation;
  • (b) ‘rapporteur Member State’ means the rapporteur Member State for the active substance as set out in Annex I;
  • (c) ‘summary dossier’ means a dossier containing the information required under Article 10(2), where summaries are given of the results of the tests and studies referred to in that paragraph;
  • (d) ‘complete dossier’ means a dossier containing the information required under Article 10(3), where the results of the tests and study reports referred to in the summary dossier are given in full.

Article 3

Designated Member State authority
1.

Each Member State shall designate an authority or authorities to carry out the obligations of the Member States as defined in this Regulation.

2.

The national authorities listed in Annex III shall coordinate and ensure all necessary contacts with notifiers, other Member States, the Commission and the European Food Safety Authority (EFSA) in accordance with this Regulation.

Each Member State shall give the details concerning the designated coordinating national authority to the Commission, the EFSA and the designated coordinating national authority of each other Member State and inform them of any modifications thereof.

CHAPTER II NOTIFICATIONS BY PRODUCERS IN NEW MEMBER STATES OF ACTIVE SUBSTANCES

Article 4

Notifications by producers in new Member States
1.

Any producer in a new Member State referred to in Article 1(1)(b) of this Regulation wishing to secure the inclusion in Annex I to Directive 91/414/EEC of an active substance listed in Annex I to this Regulation shall notify the details set out in Annex V of this Regulation to the Commission, other notifiers for that substance and the rapporteur Member State at the latest three months from the date of entry into force of this Regulation.

2.

Any producer making a notification under paragraph 1 shall fulfil the obligations of producers or notifiers set out in this Regulation for the active substance notified.

3.

Where a producer in a new Member State has not submitted a notification for an active substance listed in Annex I to this Regulation, in accordance with paragraph 1, it shall only be permitted to participate in the programme of work collectively with one or more notifiers of the active substance, including a Member State which has notified in accordance with paragraph 4 of this Article.

4.

Where no notification has been received for an active substance listed in Annex I to this Regulation, a new Member State may declare its interest in supporting the inclusion of that active substance in Annex I to Directive 91/414/EEC by notifying the Commission and the rapporteur Member State.

That notification must be submitted as soon as possible, and no later than three months from the date the Commission has informed the Member States that no notification has been submitted for that active substance.

A Member State submitting such a notification shall thereafter be treated as the producer for the purposes of the evaluation of the active substance concerned.

5.

The Commission shall decide, as provided for in the fourth subparagraph of Article 8(2) of Directive 91/414/EEC, not to include in Annex I to that Directive active substances referred to in Annex I to this Regulation for which no notification has been submitted in accordance with paragraphs 1 or 4 of this Article. The Decision shall state the reasons for the non-inclusion.

Member States shall withdraw authorisations of plant protection products containing such active substances within the period prescribed in the Decision.

CHAPTER III CONDITIONS FOR THE SUBMISSION OF DOSSIERS OF ACTIVE SUBSTANCES AND SUBMISSION OF INFORMATION BY THIRD PARTIES

Article 5

Submission of dossiers by more than one notifier
1.

Where for any active substance listed in Annex I there is more than one notifier, the notifiers concerned shall take all reasonable steps to submit the dossier for such substance collectively.

Where the dossier is not submitted by all such notifiers, it shall contain details of the efforts made and the reasons why certain notifiers have not participated in the submission of the dossier.

2.

Where an active substance has been notified by more than one notifier, those notifiers shall, for each study involving vertebrate animals, give details of the attempts made to avoid duplication of testing and give, if applicable, the reasons for conducting a duplicate study.

Article 6

Submission of dossiers to the rapporteur Member State
1.

The notifier shall submit the dossier for the active substance (the dossier) to the rapporteur Member State.

2.

The dossier shall include the following:

  • (a) a copy of the notification; in the case of a collective notification made by more than one producer as referred to in Article 5(1), it shall include:
  • (i) a copy of the notifications made in accordance with Article 4 or 5 of Regulation (EC) No 1112/2002 or Article 4 of this Regulation;
  • (ii) the name of the person designated by the producers concerned as being responsible for the collective notification who will act as a contact point during the procedure;
  • (b) a limited range of representative uses of the active substance, in respect of which the data submitted by the notifier in the dossier shall demonstrate that for one or more preparations, the requirements set out in Article 5 of Directive 91/414/EEC for inclusion of the active substance in Annex I to that Directive may be met.
3.

When requested by the rapporteur Member State as provided for in Article 20(2) to circulate the updated summary dossier or where relevant the updated complete dossier or parts thereof the notifier shall do this at the latest one month from the date of receipt of such a request.

Article 7

Dossiers for active substances submitted under Directive 98/8/EC

By derogation from Articles 5 and 6, where an active substance has been notified under Directive 98/8/EC the notifier may submit:

  • (a) a copy of the dossier submitted under Directive 98/8/EC;
  • (b) any additional information referred to in Annexes II and III to Directive 91/414/EEC necessary to justify the inclusion of the active substance in Annex I to that Directive by reference to uses falling within the scope of that Directive.

Article 8

Dossiers for active substances submitted under Regulation (EC) No 1490/2002

Where a dossier has been submitted under Regulation (EC) No 1490/2002, the person who submitted that dossier may submit, together with the further dossier submitted under this Regulation:

  • (a) a reference to the dossier submitted under Regulation (EC) No 1490/2002;
  • (b) any additional information referred to in Annexes II and III to Directive 91/414/EEC necessary to justify the inclusion of the active substance in Annex I to that Directive by reference to uses falling within the scope of this Regulation.

Article 9

Specific conditions for submissions of dossiers for active substances listed in Part A of Annex I
1.

Where the dossier concerns an active substance listed in Part A of Annex I, in addition to the information required under Article 5 and Article 6(2), the notifier shall submit the following information concerning the active substance and the plant protection product (where applicable):

  • (a) all available information on possible risks to human and animal health and the environment including that available from searching the literature and identifying the data bases searched and search terms used;
  • (b) available assessment reports from any OECD country;
  • (c) for any ongoing tests and studies not yet fully completed, information on those tests and studies and a projected date of completion.
2.

The dossier shall physically contain the individual test and study reports containing all the information referred to in paragraph 1.

3.

Each Member State shall specify the number of copies of the dossier to be submitted by the notifier when it is acting as a rapporteur and when it receives copies under Article 20(2).

The format of the dossier shall take account of the recommendations made in accordance with the procedure referred to in Article 19 of Directive 91/414/EEC.

Article 10

Specific conditions for submissions of dossiers for active substances listed in Parts B to G of Annex I
1.

Where the dossier concerns an active substance listed in Part B to G of Annex I, the notifier shall submit a dossier and a summary dossier.

2.

The notifier(s) shall include in the summarydossier:

  • (a) the information required under Article 5 and Article 6(2) of this Regulation;
  • (b) for each point of Annex II (Part A or Part B as appropriate) to Directive 91/414/EEC and for each point of Annex III (Part A or Part B as appropriate) to that Directive, the summaries and results of tests and studies and the name of the person or institute that has carried out those tests and studies;
  • (c) a checklist to be filled in by the notifier, demonstrating that the dossier is complete in accordance with Article 18 of this Regulation.

The tests and studies as referred to in paragraph 2(b) of this Article shall be those relevant to the assessment of the criteria referred to in Article 5 of Directive 91/414/EEC for one or more preparations for the uses taking into account the fact that data gaps in the dossier as regards the information required under Annex II of Directive 91/414/EEC, resulting from the proposed limited range of representative uses of the active substance, may lead to restrictions in the inclusion in Annex I of Directive 91/414/EEC.

3.

The complete dossier shall physically contain the individual test and study reports concerning all the information referred to in point (b) and the second subparagraph of paragraph 2.

4.

Each Member State shall specify the number of copies and the format of the summary and the complete dossiers to be submitted by the notifiers.

In defining the format of the complete and summary dossiers Member States shall take account of the recommendations made in accordance with the procedure referred to in Article 19 of Directive 91/414/EEC.

Article 11

Submission of information by third parties

Any natural or legal person wishing to submit relevant information which may contribute to the evaluation of an active substance listed in Annex I, in particular with regard to the potentially dangerous effects of that substance or its residues on human and animal health and on the environment, shall do so by the relevant time limit set out in Article 12.

Such information shall be submitted to the rapporteur Member State and the EFSA. When requested by the rapporteur Member State such person shall also submit that information to the other Member States at the latest one month from the date of receipt of such a request.

Article 12

Time limits for submission of dossiers

The notifier(s) shall submit the dossier to the relevant rapporteur Member State by:

  • (a) 30 June 2005 at the latest for the active substances listed in Part A of Annex I;
  • (b) 30 November 2005 at the latest for the active substances listed in Parts B to G of Annex I.

Article 13

Non-submission of dossiers
1.

Where the notifier does not submit the dossier or any part thereof within the relevant time limit set out in Article 12, the rapporteur Member State shall inform the Commission and the EFSA within two months of the date of expiry of the time limit, giving any justification for the delay provided by the notifiers.

2.

On the basis of the information submitted by the rapporteur Member State in accordance with paragraph 1, the Commission shall determine whether the notifier has demonstrated that the delay in the submission of the dossier was caused by force majeure.

In that case, it shall establish a new time limit for the submission of a dossier fulfilling the relevant requirements of Articles 5, 6, 9, and 10 of this Regulation in accordance with the procedure referred to in Article 19 of Directive 91/414/EEC.

3.

The Commission shall decide, as provided for in the fourth subparagraph of Article 8(2) of Directive 91/414/EEC, not to include in Annex I to that Directive an active substance for which no dossier has been submitted within the time limit provided for in Article 12 of this Regulation or the second subparagraph of paragraph 2 of this Article. The Decision shall state the reasons for the non-inclusion.

Member States shall withdraw authorisations of plant protection products containing such active substances within the period prescribed in the Decision.

Article 14

Replacement or withdrawal of notifier
1.

If a notifier decides to end its participation in the programme of work for an active substance, it shall immediately inform the rapporteur Member State, the Commission, the EFSA and all other notifiers of the active substance concerned of its decision, giving the reasons.

Where a notifier ends its participation or fails to fulfil its obligations under this Regulation, the procedures provided for in Articles 15 to 24 shall be terminated as regards its dossier.

2.

If a notifier agrees with another producer that the notifier shall be replaced for the purposes of further participation in the programme of work under this Regulation, the notifier and such other producer shall inform the rapporteur Member State, the Commission and the EFSA by a common declaration agreeing that such other producer shall replace the original notifier in carrying out the notifier’s duties pursuant to the relevant provisions of Articles 4, 5, 6, 9, 10, 12 and 24. They shall ensure that the other notifiers for the substance concerned are informed at the same time.

The other producer in this case shall be jointly liable with the original notifier for any fees remaining payable in relation to the notifier's application under the regime established by Member States pursuant to Article 30.

3.

If all notifiers for an active substance end their participation in the programme of work a Member State may choose to act as notifier for the purposes of further participation in the programme of work.

Any Member State wishing to act as a notifier shall inform the rapporteur Member State, the Commission and the EFSA at the latest one month from the date of being informed that all notifiers have decided to end their participation and shall replace the original notifier in carrying out the notifier’s duties pursuant to the relevant provisions of Articles 4, 5, 6, 9, 10, 12 and 24.

4.

All information submitted shall remain available to the rapporteur Member States, the Commission and EFSA

CHAPTER IV EVALUATIONS OF DOSSIERS

Article 15

General Conditions for evaluations of dossiers
1.

Without prejudice to Article 18 the rapporteur Member State shall evaluate all dossiers submitted to it.

2.

Without prejudice to Article 7 of Directive 91/414/EEC, the rapporteur Member State shall not accept the submission of new studies during the evaluation except as provided for in Article 9 (1)(c) of this Regulation.

However, the rapporteur Member State may request the notifier to submit further data which are necessary to clarify the dossier. When doing so the rapporteur Member State shall set a time limit within which the information shall be provided. The time limit shall not affect the time limit for the submission of the draft assessment report by the rapporteur Member State to the EFSA as provided for in Article 21(1) or Article 22(1).

3.

The rapporteur Member State may, from the start of the evaluation of the dossier:

  • (a) consult with experts from the EFSA;
  • (b) request additional technical or scientific information from other Member States to assist in the evaluation.
4.

Notifiers may seek specific advice from the rapporteur Member State.

Article 16

Cooperation between Member States
1.

The rapporteur Member States shall cooperate in the evaluation within each group set out in Annex I and shall organise such cooperation in the most effective and efficient way.

2.

The rapporteur Member State identified within each group in Annex I as the ‘lead rapporteur’ shall take a lead in organising that cooperation and in organising the provision of advice to notifiers where it concerns matters of general interest to the other Member States concerned.

Article 17

Specific condition for evaluations of active substances listed in Part A of Annex I

Where possible and where it does not affect the time limit for the submission of the draft assessment report as provided for in Article 21(1), the rapporteur Member State shall evaluate further information identified under Article 9(1)(c) subsequently provided by the notifier.

Article 18

Completeness check of dossiers for substances listed in Parts B to G of Annex I
1.

The rapporteur Member State shall assess the checklists provided by the notifiers in accordance with Article 10(2)(c).

2.

The rapporteur Member State shall at the latest three months from the date of receipt of all dossiers for an active substance report to the Commission on the completeness of the dossiers.

3.

For those active substances for which one or more dossiers are considered to be complete, the rapporteur Member State shall perform the evaluation as referred to in Articles 15 and 19, unless the Commission informs the rapporteur Member State, within two months of the date of receipt of the report of the rapporteur Member State on completeness, that it does not consider the dossier to be complete.

4.

For those active substances for which a rapporteur Member State or the Commission consider that no dossier is complete within the meaning of Articles 5, 6 and 10, the Commission shall, within three months from the date of the receipt of the report of the rapporteur Member State on completeness, refer such a report to the Standing Committee for the Food Chain and Animal Health.

In accordance with the procedure referred to in Article 19 of Directive 91/414/EEC it shall be decided whether a dossier is to be considered complete within the meaning of Articles 5, 6 and 10.

5.

The Commission shall decide, as provided for in the fourth subparagraph of Article 8 (2) of Directive 91/414/EEC, not to include in Annex I to Directive 91/414/EEC an active substance for which no complete dossier has been submitted within the time limit provided for in Article 12 of this Regulation or the second sub-paragraph of Article 13 (2).

Article 19

Specific conditions for evaluations of dossiers for substances listed in Parts B to G of Annex I
1.

Where active substances listed in Part D of Annex I to this Regulation have been evaluated under Directive 98/8/EC those evaluations shall be taken into account, where relevant, for the purposes of this Regulation

2.

Where active substances have been evaluated under a former stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC those evaluations shall be taken into account, where relevant, for the purposes of this Regulation.

3.

The rapporteur Member State shall evaluate and report only on those active substances for which at least one dossier has been determined to be complete in accordance with Articles 5, 6, and 10. For dossiers concerning the same active substance not determined to be complete, it shall check whether the identity and impurities of the active substance in those dossiers are comparable to the identity and impurities of the active substance in the dossiers considered complete. It shall record its views on this point in the draft assessment report.

The rapporteur Member State shall take into consideration the information available on potentially dangerous effects in the other dossiers submitted by any notifier or by any third party in accordance with Article 11.

Article 20

General conditions for draft Assessment Reports
1.

The draft assessment report shall be submitted as far as possible in the format recommended in accordance with the procedure referred to in Article 19 of Directive 91/414/EEC.

2.

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

The Member States, the Commission or the EFSA may request through the rapporteur Member State that notifiers also send them an updated complete dossier or parts thereof. The notifier shall provide any such updated dossier by the date specified in the request.

Article 21

Specific conditions for draft Assessment Reports and Recommendations to the Commission for active substances listed in Part A of Annex I
1.

The rapporteur Member State shall send the draft assessment report to the EFSA as quickly as possible, and 12 months from the date of expiry of the time limit provided for in Article 12(a) at the latest.

2.

The rapporteur Member State shall include in the draft assessment report a reference to each test or study concerning each point of Annex II (Part A or Part B as appropriate) to Directive 91/414/EEC and for each point of Annex III (Part A or Part B as appropriate) to that Directive relied on for the assessment.

That reference shall be made in the form of a list of test and study reports including the title, the author(s), the date of the study or test report and the date of publication, the standard to which the test or study was conducted, the holder’s name, and if any, the claim made by the holder or notifier for data protection.

3.

At the same time as the rapporteur Member State sends its assessment report to the EFSA as provided for in paragraph 1, it shall make a recommendation to the Commission:

  • (a) either to include the active substance in Annex I to Directive 91/414/EEC stating where appropriate the proposed conditions for inclusion; such conditions:
  • (i) may include the time limit for such inclusion;
  • (ii) shall state whether any information is required, whether such additional information is included in the tests and studies referred to in Article 9(1)(c) of this Regulation and if so, the probable timetable for the provision of such information; or
  • (b) not to include the active substance in Annex I to Directive 91/414/EEC, stating the proposed reasons for the non-inclusion.
4.

In addition to the conditions for inclusion proposed under paragraph 2(a) of this Article, the rapporteur Member State may indicate if it has identified, for the proposed limited range of representative uses mentioned in the dossier, any information missing from the dossier which may be required by Member States as confirmatory information when they come to grant authorisations under Article 4 of Directive 91/414/EEC for plant protection products containing that active substance.

Article 22

Specific conditions for draft Assessment Reports and Recommendations to the Commission for active substances listed in Parts B to G of Annex I
1.

The rapporteur Member State shall send a draft assessment report to the EFSA as quickly as possible, and at the latest 12 months from the date the dossier was determined to be complete in accordance with Article 18(2).

2.

The rapporteur Member State shall include in the draft assessment report a reference to each test or study concerning each point of Annex II (Part A or Part B as appropriate) to Directive 91/414/EEC and for each point of Annex III (Part A or Part B as appropriate) to that Directive relied on for the assessment.

That reference shall be made in the form of a list of test and study reports including the title, the author(s), the date of the study or test report and the date of publication, the standard to which the test or study was conducted, the holder’s name and, if any, the claim made by the holder or notifier for data protection.

3.

At the same time as the rapporteur Member State sends its assessment report to the EFSA as provided for in paragraph 1, it shall make a recommendation to the Commission:

  • (a) either to include the active substance in Annex I to Directive 91/414/EEC, stating the reasons for the inclusion;
  • (b) or not to include the active substance in Annex I to Directive 91/414/EEC, stating the reasons for the non-inclusion.

Article 23

Replacement of rapporteur Member State
1.

A rapporteur Member State shall inform the Commission and the EFSA as soon as it becomes clear that it will be unable to comply with the time limits set out in Articles 21(1) and 22(1) for the submission of the draft assessment report to the EFSA and give the reasons for the delay.

2.

It may be decided to replace a rapporteur Member State for a particular active substance by another Member State where:

  • (a) during the assessment and evaluation provided for in Articles 15, 16, 17 and 19 it becomes apparent that there is an imbalance in the responsibilities borne and the work to be done or actually done by the Member States as rapporteurs; or
  • (b) it is clear that a Member State is unable to fulfil its obligations under this Regulation.

Such replacement shall be decided in accordance with the procedure referred to in Article 19 of Directive 91/414/EEC.

3.

Where it has been decided to replace a rapporteur Member State the original rapporteur Member State shall immediately after such a decision has been taken inform the notifiers concerned and shall transfer to the newly designated rapporteur Member State all correspondence and information which it has received as rapporteur Member State for the active substance concerned.

The original Member State shall return to the notifier the part of the fee referred to in Article 30 which has not been used. The newly designated rapporteur Member State may require the payment of a further fee in accordance with Article 30.

Article 24

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 21(1) or Article 22(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, the 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 24a

Evaluation 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 24(2).

Article 24b

Active substances 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 VI, Article 25(1)(a) and (2)(a) shall apply.

Article 24c

Consultation of the EFSA
1.

Where Article 24b 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 VII. 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 VII, the EFSA shall inform the Commission.

The Commission may take a Decision as referred to in Article 24f.

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 24d

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 24c, 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 24e

Withdrawal by notifier

Where Article 24b 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 24(2).

Article 24f

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 VII 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 25(1)(a) and (2)(b) of this Regulation.

CHAPTER V PRESENTATION OF A DRAFT DIRECTIVE OR DRAFT DECISION CONCERNING ACTIVE SUBSTANCES AND FINALISED REVIEW REPORT

Article 25

Presentation of a draft directive or draft decision
1.

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

  • (a) receipt of the draft assessment report where Article 24b or Article 24f applies;
  • (b) receipt of the conclusion by the EFSA where Article 24c applies;
  • (c) receipt of a written withdrawal of the notifier’s support where Article 24e 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 point (b) of paragraph 2, the latest date for Member States to withdraw authorisations shall be 31 December 2010 in the case referred to in point (c) of paragraph 1 unless the Commission concluded that the substance meets the criteria of Annex VII, if appropriate after having consulted the EFSA.  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 ([^E0010]).

Article 25a

View by the EFSA

Where an active substance is included in Annex I to Directive 91/414/EEC pursuant to Article 24b of this Regulation, the Commission shall request the EFSA to deliver its view on the draft review report by  31 December 2012 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.

Article 26

Finalised review report

The conclusions of the Standing Committee on the Food Chain and Animal Health, excluding any parts which refer to confidential information contained in the dossiers and determined as such in accordance with Article 14 of Directive 91/414/EEC, shall be made publicly available.

CHAPTER VI SUSPENSION OF TIME LIMITS, MEASURES TO BE TAKEN BY MEMBER STATES AND INTERIM PROGRESS REPORTS

Article 27

Suspension of time limits

Where, in respect of an active substance listed in Annex I to this Regulation, the Commission presents a proposal for a total prohibition by way of a draft Council act based on Article 6(3) of Directive 79/117/EEC, the time limits provided for in this Regulation shall be suspended while the Council considers that proposal.

Where the Council adopts an amendment to the Annex to Directive 79/117/EEC requiring the total prohibition of that active substance, the procedure under this Regulation shall be terminated for that active substance.

Article 28

Measures taken by Member States

Any Member State which, on the basis of information contained in the dossiers referred to in Articles 5 to 10 or in the draft assessment report concerning an active substance referred to in Articles 19 to 22, intends taking action to withdraw that active substance from the market or to restrict severely the use of a plant protection product containing that active substance, shall, as soon as possible, inform the Commission, the EFSA, the other Member States and the notifiers giving the reasons for its intended action.

Article 29

Interim progress report

All Member States shall submit to the Commission and the EFSA a report of their progress on the evaluation of the active substances for which they are rapporteur. Such report shall be submitted by:

  • (a) 30 November 2005 for the active substances listed in Part A of Annex I;
  • (b) 30 November 2006 for the active substances listed in Parts B to G of Annex I.

CHAPTER VII FEES AND OTHER CHARGES

Article 30

Fees
1.

For active substances listed in Annex I Member States may establish a regime obliging the notifiers to pay a fee or charge for the administrative treatment and the evaluation of dossiers.

The income from such fees or charges shall be used to finance exclusively those costs actually incurred by the rapporteur Member State or to finance general activities of the Member States resulting from their obligations under Articles 15 to 24.

2.

Member States shall establish the amount of the fee or charge referred to in paragraph 1 in a transparent manner so that it does not exceed the real cost of the examination and administrative treatment of a dossier or the general activities of the Member States resulting from their obligations under Articles 15 to 24.

However, Member States may provide for a scale of fixed charges based on average costs for the calculation of the total fee.

3.

The fee or charge shall be paid in accordance with the procedure to be established by the authorities in each Member State as listed in Annex IV.

Article 31

Other charges, taxes, levies or fees

Article 30 shall be without prejudice to Member States' rights to maintain or introduce, to the extent permitted under Community law, charges, taxes, levies or fees with regard to authorisation, placing on the market, use and control of active substances and plant protection products other than the fee or charge provided for in that Article.

CHAPTER VIII TEMPORARY AND FINAL PROVISIONS

Article 32

Temporary measures

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

Article 33

Entry into force

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

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

ANNEX I

List of active substances (column A), rapporteur Member States (column B) and notifying producers (code identification) (column C) ([^E0011])

PART A

GROUP 1
LEAD RAPPORTEUR: IRELAND
Active substance Rapporteur Member State Notifier
(A) (B) (C)
Acetic acid Germany PAB-SE PUN-DK TEM-DE
Amino acids/Gamma Aminobutyric acid Germany AGR-ES
————— ————— —————
Ammonium carbonate Ireland ABC-GB
Potassium hydrogen carbonate Ireland PPP-FR
Sodium hydrogen carbonate Ireland CLM-NL SLY-FR
Casein Czech Republic
3-phenyl-2-propenal (Cinnamaldehyde) Poland
Ethoxyquin Germany XED-FR
Fatty acids/Decanoic acid Ireland PBI-GB
Fatty acids/Fatty acid methyl ester (CAS 85566-26-3) Ireland OLE-BE
Fatty acids/Fatty acid potassium salt Ireland FBL-DE IAB-ES NEU-DE
Fatty acids/Fatty acid potassium salt (CAS 7740-09-7) Ireland DKI-NL
Fatty acids/Fatty acid potassium salt (CAS 10124-65-9) Ireland ERO-IT
Fatty acids/Fatty acid potassium salt (CAS 13429-27-1, 2624-31-9, 593-29-3, 143-18-0, 3414-89-9, 38660-45-6, 18080-76-7) Ireland DXN-DK
Fatty acids/Fatty acid potassium salt (CAS 18175-44-5, 143-18-0, 3414-89-9) Ireland DXN-DK
Fatty acids/Fatty acid potassium salt (CAS 61788-65-6) Ireland TBE-ES
Fatty acids/Fatty acid potassium salt (CAS 61790-44-1) Ireland VAL-IT
Fatty acids/Fatty acid potassium salt (CAS 61790-44-1, 70969-43-6) Ireland STG-GB
Fatty acids/Fatty acid potassium salt (CAS 67701-09-1) Ireland CRU-IT
Fatty acids/Heptanoic acid Ireland DKI-NL
Fatty acids/Octanoic acid Ireland PBI-GB
Fatty acids/Oleic acid Ireland ALF-ES
Fatty acids/Pelargonic acid Ireland ERO-IT NEU-DE
Fatty acids/potassium salt — decanoic acid (CAS 334-48-5) Ireland NSC-GB
Fatty acids/potassium salt — caprylic acid (CAS 124-07-2) Ireland ADC-DE
Fatty acids/potassium salt — lauric acid (CAS 143-07-7) Ireland NSC-GB
Fatty acids/potassium salt — oleic acid (CAS 112-80-1) Ireland NSC-GB
Fatty acids/potassium salt — oleic acid (CAS 112-80-1, 1310-58-3) Ireland BCS-DE
Fatty acids/potassium salt — oleic acid (CAS 142-18-0) Ireland SBS-IT
Fatty acids/potassium salt — oleic acid (CAS 143-18-0) Ireland VIO-GR STG-GB
Fatty acids/potassium salt — pelargonic acid(CAS 112-05-0) Ireland NSC-GB
Fatty acids/potassium salt — tall oil fatty acid (CAS 61790-12-3) Ireland ADC-DE
Fatty acids/tall oil fatty acids (CAS 61790-12-3) Ireland ACP-FR
Fatty acids/Isobutyric acid Poland
Fatty acids/Isovaleric acid Poland
Fatty acids/Lauric acid Ireland
Fatty acids/Valeric acid Poland
Fatty acids/Potassium salt of natural oil acids Poland
Formic acid Germany KIR-NL
Iron pyrophosphate Slovenia
————— ————— —————
Milk albumin Czech Republic
————— ————— —————
Urea (see also Group 6.2.) Greece FOC-GB OMX-GB
————— ————— —————
Propolis Poland
GROUP 2
Group 2.1.
LEAD RAPPORTEUR: FRANCE
Active substance Rapporteur Member State Notifier
(A) (B) (C)
1-Naphthylacetamide France ALF-ES AMV-GB CFP-FR GLO-BE GOB-IT HOC-GB HRM-BE LUX-NL PRO-ES SHC-FR SPU-DE
Naphthylacetic acid France AIF-IT ALF-ES AMV-GB CFP-FR FIN-GB GLO-BE GOB-IT HOC-GB HRM-BE LUX-NL PRO-ES RHZ-NL SHC-FR VAL-IT
2-Naphthyloxyacetamide France BCS-FR
2-Naphthyloxyacetic acid France AIF-IT ASP-NL HAS-GR HOC-GB SHC-FR
6-Benzyladenine France ALF-ES CAL-FR FIN-GB GLO-BE GOB-IT HOC-GB HRM-BE NLI-AT SUM-FR VAL-IT
Azadirachtin Germany AGI-IT ALF-ES CAP-FR CRU-IT FBL-DE IAB-ES MAS-BE NDC-SE PBC-ES PRO-ES SIP-IT TRF-DE VAL-IT
Cis-Zeatin Italy VAL-IT
Folic acid France AMI-IT CHE-DK ISA-IT
Indolylacetic acid France ALF-ES GOB-IT RHZ-NL
Indolylbutyric acid France ALF-ES BCS-FR CRT-GB GOB-IT GTL-GB HOC-GB RHZ-NL
Gibberellic acid Hungary AIF-IT ALF-ES ALT-FR CEQ-ES FIN-GB GLO-BE HRM-BE NLI-AT PRO-ES SUM-FR VAL-IT
Gibberellin Hungary ALF-ES FIN-GB GLO-BE GOB-IT HRM-BE NLI-AT SUM-FR
Nicotine United Kingdom JAH-GB PBC-ES UPL-GB
Pyrethrins Italy ALF-ES BRA-GB CAP-FR FBL-DE MGK-GB ORI-GB PBC-ES PBK-AT PYC-FR SAM-FR SBS-IT
Rotenone France FBL-DE IBT-IT SAP-FR SBS-IT SFS-FR
Group 2.2.
LEAD RAPPORTEUR: UNITED KINGDOM
Active substance Rapporteur Member State Notifier
(A) (B) (C)
Citronellol (see also Group 6.1) United Kingdom ACP-FR
————— ————— —————
Citrus extract/grapefruit extract United Kingdom
Citrus extract/Grapefruit seed extract Notified as Disinfectant United Kingdom BOB-DK
Conifer needle powder Latvia
Garlic extract Notified as repellant Poland ALF-ES-016 CRU-IT-005 ECY-GB-001 IAB-ES-001 PBC-ES-004 SBS-IT-003 SIP-IT-002 TRD-FR-001 VAL-IT-011
Garlic pulp Poland
Extract from Equisetum Latvia
Lecithin Italy DUS-DE FBL-DE PBC-ES
————— ————— —————
Mustard powder Latvia
Pepper Notified as repellant United Kingdom BOO-GB PBI-GB
————— ————— —————
Plant oils/Citronella oil United Kingdom BAR-GB PBI-GB
Plant oils/Clove oil Notified as repellant United Kingdom IAS-SE XED-FR
Plant oils/Etheric oil (Eugenol) Notified as repellant Sweden DEN-NL DKI-NL
————— ————— —————
Plant oils/Gaiac Wood oil Spain IAS-SE
Plant oils/Garlic oil United Kingdom DEN-NL GSO-GB
Plant oils/Lemongrass oil Notified as repellant United Kingdom IAS-SE
————— ————— —————
Plant oils/Olive oil United Kingdom DKI-NL
Plant oils/Orange oil Notified as repellant United Kingdom GSO-GB
Plant oils/Pinus oil Sweden ACP-FR DKI-NL IBT-IT MIB-NL SPU-DE
Plant oils/Rape seed oil Spain CEL-DE CRU-IT DKI-NL FBL-DE NEU-DE NOV-FR PBI-GB VIT-GB
Plant oils/Soya oil Notified as repellant Sweden DEN-NL DKI-NL PBC-ES
Plant oils/Spear mint oil Sweden XED-FR
Plant oils/Sunflower oil Spain DKI-NL PBI-GB TRD-FR
————— ————— —————
Plant oils/Ylang-Ylang oil Notified as repellant Sweden IAS-SE
Quassia Italy AGE-IT CAP-FR FBL-DE TRF-DE ALF-ES
Sea-algae extract Italy ASU-DE LGO-FR OGT-IE VAL-IT
Seaweed Italy ASF-IT OGT-IE VAL-IT ALF-ES ESA-NL BAL-IE AGC-FR
Extract from plant Red oak, Pronikly pear cactus, Fragrant sumac, Red mangrove Poland
Extract from Menta piperata Poland
Extract from tea tree Latvia
GROUP 3
LEAD RAPPORTEUR: DENMARK
Active substance Rapporteur Member State Notifier
(A) (B) (C)
Chitosan Denmark ALF-ES CLM-NL IDB-ES
Gelatine Denmark MIB-NL
Hydrolysed proteins (see also Group 6.2) Greece SIC-IT
GROUP 4
LEAD RAPPORTEUR: UNITED KINGDOM
Active substance Rapporteur Member State Notifier
(A) (B) (C)
1-Decanol Italy CRO-GB OLE-BE JSC-GB
Aluminium sulphate Spain FER-GB GSO-GB
Calcium chloride Spain FBL-DE
Calcium hydroxide Spain PZD-NL
Carbon monoxide United Kingdom
Carbon dioxide Notified as insecticide/disinfectant United Kingdom FBL-DE
EDTA and salts thereof Hungary DKI-NL
Fatty alcohols/Aliphatic alcohols Italy JSC-GB
Iron sulphate United Kingdom BNG-IE HTO-GB KRO-DE MEL-NL
Kieselgur (Diatomaceous earth) Greece ABP-DE AGL-GB AMU-DE DKI-NL FBL-DE
Lime sulphur (Calcium polysulphide) Spain FBL-DE PLS-IT STI-IT
Paraffin oil Greece FBL-DE
Paraffin oil/(CAS 64741-88-4) Greece BPO-GB SUN-BE
Paraffin oil/(CAS 64741-89-5) Greece BPO-GB PET-PT SUN-BE SUN-BE XOM-FR
Paraffin oil/(CAS 64741-97-5) Greece BPO-GB
Paraffin oil/(CAS 64742-46-7) Greece TOT-FR TOT-FR TOT-FR
Paraffin oil/(CAS 64742-54-7) Greece CVX-BE
Paraffin oil/(CAS 64742-55-8/64742-54-7) Greece SAG-FR
Paraffin oil/(CAS 64742-55-8) Greece CPS-ES CVX-BE XOM-FR
Paraffin oil/(CAS 64742-65-0) Greece XOM-FR
Paraffin oil/(CAS 72623-86-0) Greece TOT-FR
Paraffin oil/(CAS 8012-95-1) Greece AVA-AT
Paraffin oil/(CAS 8042-47-5) Greece ASU-DE ECP-DE NEU-DE
Paraffin oil/(CAS 97862-82-3) Greece TOT-FR TOT-FR
Petroleum oils Spain FBL-DE
Petroleum oils/(CAS 64742-55-8/64742-57-7) Spain GER-FR
Petroleum oils/(CAS 74869-22-0) Spain CVX-BE RLE-ES
Petroleum oils/(CAS 92062-35-6) Spain RML-IT
Potassium permanganate Spain CNA-ES FBL-DE VAL-IT
Aluminium silicate (Kaolin) Hungary PPP-FR
Sodium aluminium silicate Notified as repellant Hungary FLU-DE
Sulphur France ACI-BE AGN-IT BAS-DE CER-FR CPS-ES FBL-DE GOM-ES HLA-GB JCA-ES NSC-GB PET-PT RAG-DE RLE-ES SAA-PT SML-GB STI-IT SYN-GB UPL-GB ZOL-IT
Sulphuric acid France NSA-GB
Calcium carbonate Spain
GROUP 5
LEAD RAPPORTEUR: SPAIN
Active substance Rapporteur Member State Notifier
(A) (B) (C)
2-Phenylphenol Spain BCH-DE
Ethanol France CGL-GB
Ethylene United Kingdom BRM-GB COL-FR
GROUP 6
Group 6.1.
LEAD RAPPORTEUR: BELGIUM
Active substance Rapporteur Member State Notifier
(A) (B) (C)
Aluminium ammonium sulfate Portugal SPL-GB
Ammonium acetate Portugal LLC-AT
Anthraquinone Belgium TOM-FR
Bone oil Notified as Repellant Belgium BRI-GB FLU-DE IOI-DE ASU-DE
Calcium carbide Portugal CFW-DE
Citronellol Notified as Repellant (see also Group 2.2) United Kingdom ASU-DE CAL-FR
Denathonium benzoate Portugal ASU-DE MFS-GB
Dodecyl alcohol Portugal SEI-NL
Lanolin Slovak Republic
Methyl nonyl ketone Belgium PGM-GB
Polymer of styrene and acrylamide Slovak Republic
————— ————— —————
Repellants (by smell) of animal or plant origin/Blood meal Belgium GYL-SE
Repellants (by smell) of animal or plant origin/Essential oils Belgium BAR-GB
Trimethylamine hydrochloride Belgium LLC-AT
Repellant (by taste) of vegetal and animal origin/extract of food grade/phosphoric acid and fish flour Belgium
2-hydroxyethyl butyl sulfide Poland
Asphalts Poland
Group 6.2.
LEAD RAPPORTEUR: GREECE
Active substance Rapporteur Member State Notifier
(A) (B) (C)
————— ————— —————
Daphne oil Slovenia FLU-DE
Hydrolysed proteins Notified as Attractant (see also Group 3.) Greece BIB-ES PHY-GR SIC-IT
Limestone — pulverized Austria
Olein Hungary
Quartz sand Austria ASU-DE AVA-AT DKI-NL FLU-DE
Repellants (by smell) of animal or plant origin/Fatty acids, fish oil Greece ASU-DE
Repellants (by smell) of animal or plant origin/Fish oil Greece FLU-DE
Repellants (by smell) of animal or plant origin/Sheep fat Greece KWZ-AT
Repellants (by smell) of animal or plant origin/Tall oil (CAS 8016-81-7) Greece FLU-DE
Repellants (by smell) of animal or plant origin/Tall oil crude (CAS 93571-80-3) Greece ASU-DE
Repellants (by smell) of anímal or plant origin/tall oil Greece
Urea (see also Group 1) Greece PHY-GR
Chinin hydrochlorid Hungary

PART B

LEAD RAPPORTEUR: AUSTRIA
RAPPORTEUR: AUSTRIA
(The Czech Republic, Poland and Italy shall be considered the rapporteur Member States in the sense of the obligation to cooperate with Austria in the evaluation, in accordance with the provisions of Article 16)
Active substance Rapporteur Member State Notifier
(A) (B) (C)
(2E,13Z)-Octadecadien-1-yl acetate SEI-NL SEI-NL SEI-NL
(7E,9Z)-Dodecadienyl acetate BAS-DE CAL-FR ISA-IT LLC-AT RUS-GB SDQ-ES SEI-NL
(7E,9Z)-Dodecadienyl acetate; (7E,9E)-Dodecadienyl acetate SHC-FR
(7Z,11E)-Hexadecadien-1-yl acetate SEI-NL SEI-NL
(7Z,11Z)-Hexadecadien-1-yl acetate; (7Z,11E)-Hexadecadien-1-yl acetate ABC-GB LLC-AT
(9Z,12E)-Tetradecadien-1-yl acetate RUS-GB
E)-11-Tetradecenyl acetate SEI-NL
(E)-8-Dodecenyl acetate CAL-FR SEI-NL
(E,E)-8,10-Dodecadien-1-ol BAS-DE CAL-FR ISA-IT LLC-AT RUS-GB SDQ-ES SEI-NL SHC-FR VIO-GR MAS-BE
(E/Z)-8-Dodecenyl acetate; (Z)-8-Dodecenol BAS-DE CAL-FR
(E/Z)-9-Dodecenyl acetate; (E/Z)-9-Dodecen-1-ol; (Z)-11-Tetradecen-1-yl acetate ISA-IT LLC-AT SDQ-ES
(E/Z)-9-Dodecenyl acetate; (E/Z)-9-Dodecen-1-ol; (Z)-11-Tetradecen-1-yl acetate TRF-DE
(Z)-11-Hexadecen-1-ol SEI-NL
(Z)-11-Hexadecen-1-yl acetate SEI-NL
(Z)-11-Hexadecenal SEI-NL
(Z)-11-Hexadecenal; (Z)-11-Hexadecen-1-yl acetate LLC-AT
(Z)-11-Tetradecen-1-yl acetate BAS-DE SEI-NL
(Z)-13-Hexadecen-11-ynyl acetate SDQ-ES
(Z)-13-Octadecenal SEI-NL
(Z)-7-Tetradecenal SEI-NL
(Z)-8-Dodecenol SEI-NL
(Z)-8-Dodecenyl acetate CAL-FR SDQ-ES SEI-NL
(Z)-8-Dodecenyl acetate; Dodecan-1-yl acetate ISA-IT
(Z)-9-Dodecenyl acetate BAS-DE LLC-AT SDQ-ES SEI-NL SHC-FR
(Z)-9-Dodecenyl acetate; Dodecan-1-yl acetate ISA-IT
(Z)-9-Hexadecenal SEI-NL
(Z)-9-Hexadecenal; (Z)-11-Hexadecenal; (Z)-13-Octadecenal RUS-GB SDQ-ES
(Z)-9-Tetradecenyl acetate SEI-NL
————— ————— —————
(Z,Z,Z,Z)-7,13,16,19-Docosatetraen-1-yl isobutyrate SHC-FR
1,4-Diaminobutane (Putrescine) Austria LLC-AT
————— ————— —————
1-Tetradecanol SEI-NL
2,6,6-Trimethylbicyclo[3.1.1]hept-2-ene(alpha-Pinen) SHC-FR
3,7,7-Trimethylbicyclo[4.1.0]hept-3-ene (3-Carene)
————— ————— —————
5-Decen-1-ol BAS-DE SEI-NL
5-Decen-1-yl acetate BAS-DE SEI-NL
5-Decen-1-yl acetate; 5-Decen-1-ol LLC-AT ISA-IT
(8E, 10E) – 8, 10 – Dodecadiene 1- yl acetate
Dodecan- 1 - yl acetate
(E) – 9- Dodecen – 1 – yl acetate
(E) – 8- Dodecen – 1 – yl acetate
2-Methyl-6-methylene-2,7-octadien-4-ol (ipsdienol)
4,6,6-Trimethyl-bicyclo[3.1.1]hept-3-en-ol,((S)-cis-verbenol)
2-Ethyl-1,6-dioxaspiro(4,4) nonan(chalcogran)
(IR)-1,3,3-Trimethyl-4,6-dioxatricyclo[3.3.1.02,7] nonane (lineatin)
(E,Z)-8,10-Tetradecadienyl
2-ethyl-1,6-Dioxaspiro (4,4) nonan
2-Methoxypropan-1-ol
2-Methoxypropan-2-ol
2-Methyl-3-buten-2-ol
(E)-2-Methyl-6-methylene-2,7-octadien-1-ol(myrcenol)
————— ————— —————
2-Methyl-6-methylene-7-octen-4-ol (Ipsenol)
3-Methyl-3-buten-1-ol
————— ————— —————
Methyl p-hydroxybenzoate
p-Hydroxybenzoic acid
1-Methoxy-4-propenylbenzene (Anethole)
1-Methyl-4-isopropylidenecyclohex-1-ene (Terpinolene)

PART C

LEAD RAPPORTEURS: NETHERLANDS, SWEDEN
Active substance Rapporteur Member State Notifier
(A) (B) (C)
Agrobacterium radiobacter K 84 Denmark
Bacillus sphaericus France SUM-FR
Bacillus subtilis strain IBE 711 Germany
Bacillus thuringiensis aizawai Italy ISA-IT MAS-BE SIP-IT SUM-FR
Bacillus thuringiensis israelensis Italy SIP-IT SUM-FR
Bacillus thuringiensis kurstaki Denmark ALF-ES ASU-DE IAB-ES MAS-BE PRO-ES SIP-IT SUM-FR IBT-IT ISA-IT
Bacillus thuringiensis tenebrionis Italy SUM-FR
Baculovirus GV Germany
Beauveria bassiana Germany AGI-IT AGR-ES CAL-FR MEU-GB
Beauveria brongniartii Germany CAL-FR
Cydia pomonella granulosis virus Germany MAS-BE CAL-FR PKA-DE SIP-IT
Metarhizium anisopliae Netherlands AGF-IT IBT-IT TAE-DE
Neodiprion sertifer nuclear polyhedrosis virus Finland VRA-FI
Phlebiopsis gigantea Estonia FOC-GB VRA-FI
Pythium oligandrun Sweden
Streptomyces griseoviridis Estonia VRA-FI
Trichoderma harzianum Sweden BBI-SE IAB-ES IBT-IT ISA-IT AGF-IT BOB-DK KBS-NL
Trichoderma polysporum Sweden BBI-SE
Trichoderma viride France AGB-IT ISA-IT
Verticillium dahliae Netherlands ARC-NL
Verticillium lecanii Netherlands KBS-NL

PART D

LEAD RAPPORTEUR: GERMANY
Active substance Rapporteur Member State Notifier
(A) (B) (C)
Aluminium phosphide Germany CAT-PT DET-DE
Brodifacum Italy PEL-GB
Bromadiolone Sweden ABB-GB CAL-FR LIP-FR
Chloralose Portugal PHS-FR
Chlorophacinone Spain CAL-FR CFW-DE FRU-DE LIP-FR
Difenacoum Finland APT-GB CAL-FR SOX-GB
Magnesium phosphide Germany DET-DE
Tricalcium phosphate Germany CHM-FR
Zinc phosphide Germany CFW-DE
Carbon monoxide Italy

PART E

Active substance Rapporteur Member State Notifier
(A) (B) (C)
Aluminium phosphide Germany DET-DE UPL-GB
Magnesium phosphide Germany DET-DE UPL-GB

PART F

LEAD RAPPORTEUR: NETHERLANDS
Active substance Rapporteur Member State Notifier
(A) (B) (C)
Didecyl-dimethylammonium chloride Netherlands LON-DE
Formaldehyde Notified as Disinfectant Netherlands PSD-GB
Glutaraldehyde Belgium BAS-DE
HBTA (High Boiling Tar Acid) Notified as Disinfectant Ireland JEY-GB
Hydrogen peroxide Finland FBL-DE KIR-NL SPU-DE
Peracetic acid Netherlands SOL-GB
Phoxim Finland BCS-DE
Sodium hypochlorite Netherlands SPU-DE
————— ————— —————
Sodium p-toluenesulphon-chloramide Netherlands PNP-NL

PART G

LEAD RAPPORTEUR: POLAND
Active substance Rapporteur Member State Notifier
(A) (B) (C)
2-Methoxy-5-nitrofenol sodium salt Poland
3(3-Benzyloxycarbonyl-methyl)-2-benzothiazolinone (Benzolinone) Slovak Republic
Cumylphenol Poland
Fat destilation residues Czech Republic
Flufenzin Hungary
Flumetsulam Slovak Republic
Ethanedial (glyoxal) Poland
Hexamethylene tetramine (urotropin) Slovak Republic
Lactofen Czech Republic
Propisochlor Hungary
2-Mercaptobenzothiazole Poland
Biohumus Poland
————— ————— —————
Jasmonic acid Hungary
N-phenylphthalamic acid Hungary
Copper complex: 8-hydroxyquinolin with salicylic acid Poland
1,3,5-Tir-(2-hydroxyethyl)-hexa-hydro-s-triazyne Poland

ANNEX II

List of notifiers' code identification, names and addresses

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