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Document 02004R2229-20100302
Commission Regulation (EC) No 2229/2004 of 3 December 2004 laying down further detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC (Text with EEA relevance)
Consolidated text: Commission Regulation (EC) No 2229/2004 of 3 December 2004 laying down further detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC (Text with EEA relevance)
Commission Regulation (EC) No 2229/2004 of 3 December 2004 laying down further detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC (Text with EEA relevance)
2004R2229 — EN — 02.03.2010 — 003.001
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
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COMMISSION REGULATION (EC) No 2229/2004 of 3 December 2004 laying down further detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC (OJ L 379, 24.12.2004, p.13) |
Amended by:
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Official Journal |
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No |
page |
date |
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L 151 |
26 |
13.6.2007 |
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COMMISSION REGULATION (EC) No 1095/2007 of 20 September 2007 |
L 246 |
19 |
21.9.2007 |
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L 37 |
12 |
10.2.2010 |
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COMMISSION REGULATION (EC) No 2229/2004
of 3 December 2004
laying down further detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market ( 1 ), and in particular the second subparagraph of Article 8(2) thereof,
Whereas:|
(1) |
Directive 91/414/EEC provides for the Commission to undertake a programme of work within a period of 12 years (the programme of work) following the notification of that Directive for the gradual examination of active substances on the market two years after the date of notification of that Directive. |
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(2) |
Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market ( 2 ) provides for the first stage of the programme of work and is still ongoing. |
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(3) |
Commission Regulation (EC) No 451/2000 of 28 February 2000 laying down the detailed rules for the implementation of the second and third stages of the work programme referred to in Article 8(2) of Council Directive 91/414/EEC ( 3 ) provides for the second stage of the programme of works and is also ongoing. |
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(4) |
Regulation (EC) No 451/2000 also provides for a third stage of the programme of works for an additional number of active substances not covered by the first and second stages of the programme. Commission Regulation (EC) No 1490/2002 of 14 August 2002 laying down further detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC and amending Regulation (EC) No 451/2002 ( 4 ) also provides for the third stage of the programme of works. The third stage is also ongoing. |
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(5) |
Commission Regulation (EC) No 1112/2002 of 20 June 2002 laying down the detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC ( 5 ) provides for the fourth stage of work and is ongoing. Producers wishing to support the inclusion of the active substances covered by that stage in Annex I to Directive 91/414/EEC have undertaken to provide the necessary information. |
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(6) |
By reason of the accession of the Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and Slovakia, it is necessary to provide the opportunity for producers in those new Member States to notify their interest to participate in stage four of the programme of work for all substances covered under that stage. It is also appropriate to organise the review of substances that were on the market in a new Member State before 1 May 2004 and which are not included in stages one to four of the programme of work. |
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(7) |
The procedures established in this Regulation should not prejudice procedures and actions to be undertaken in the framework of other Community legislation, in particular under Council Directive 79/117/EEC of 21 December 1978 prohibiting the placing on the market and use of plant protection products containing certain active substances ( 6 ), where information becomes available to the Commission showing that its requirements may be satisfied. |
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(8) |
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety ( 7 ) created the European Food Safety Authority (EFSA) to ensure that the Community has access to high-quality, independent and efficient scientific and technical support in order to achieve a high level of health protection in relation to legislation concerning safety of food and feed. It is therefore appropriate to provide that the EFSA should have a role in the programme of work on active substances. |
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(9) |
The relationships between producers, Member States, the Commission and the EFSA and the obligations on each of them for the implementation of the programme of work should be laid down, taking into account experience gained during the first and second stages of the programme of work, the objective of separating risk assessment from risk management and the need to organise the work in the most efficient way. |
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(10) |
Close cooperation between producers, Member States, the Commission and the EFSA and a scrupulous respect of time limits laid down is necessary to ensure the efficiency of the programme of work. Strict time limits for all elements of the fourth stage of that programme should be set in order to ensure its finalisation within an acceptable time period. For certain active substances where the dossier requirements are limited, a short deadline for submission of the dossier is appropriate in order to allow the opportunity for further information to be provided within the overall time-frame for completion of the review programme. |
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(11) |
In order to avoid duplication of work, and in particular experiments involving vertebrate animals, producers should be encouraged to submit collective dossiers. |
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(12) |
It is necessary to define the obligations of producers with regard to the formats, time periods and national authorities and the EFSA for the information to be submitted. Many of the active substances covered by stage four of the programme of work are produced in small volume for specialist purposes. Some are important in organic or other low input farming systems and may be expected to constitute a low risk in terms of human and environmental protection. |
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(13) |
The Commission identified in its progress Report to the European Parliament and the Council — Evaluation of the active substances of plant protection products (submitted in accordance with Article 8(2) of Council Directive 91/414/EEC on the placing of plant protection products on the market) ( 8 ) the need for special measures to be adopted in relation to low-risk compounds. |
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(14) |
A modified approach is required for this stage of the programme of work to reduce the risk that large numbers of active substances will be withdrawn for economic reasons alone. For certain groups of active substances it is, therefore, appropriate that the format and requirements for the information to be submitted are different from those developed for active substances in the previous three stages of the programme of work. |
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(15) |
In the interests of consistency of Community legislation it is necessary to ensure that the measures provided for in this Regulation are coherent with measures taken under Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market ( 9 ). |
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(16) |
The notification and submission of a dossier should not be a prerequisite for the possibility, after inclusion of the active substance in Annex I to Directive 91/414/EEC, to place plant protection products on the market subject to the provisions of Article 13 of that Directive. Therefore persons who have not submitted notifications should be able to be informed at all stages of the evaluation process of the possible further requirements for continued marketing of plant protection products containing an active substance under evaluation. |
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(17) |
In order to ensure that all relevant information on the potentially dangerous effects of an active substance or its residues are considered, technical or scientific information submitted within the relevant time limits by any person should also be taken into consideration in the evaluations. |
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(18) |
Where cooperation with notifiers ceases, it is impossible to continue further evaluation efficiently and therefore the evaluation of an active substance should be terminated unless a Member State takes over. |
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(19) |
The task of evaluation should be distributed among the competent authorities of the Member States. Therefore, for each active substance a rapporteur Member State should be designated. Where appropriate the rapporteur Member State should assess the completeness checklist provided by the notifier, and examine and evaluate the information submitted. It should present to the EFSA the results of the evaluation and make a recommendation to the Commission concerning the decision to be taken with regard to the active substance concerned. For certain groups of active substances it is appropriate that the rapporteur Member States closely cooperate with other rapporteur Member States for that group. For each group it is appropriate to identify a lead rapporteur to coordinate such cooperation. |
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(20) |
Rapporteur Member States should send draft assessment reports of their evaluations of active substances to the EFSA. The draft assessment reports should be peer reviewed by the EFSA before they are submitted to the Commission. |
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(21) |
In case of an apparent imbalance in the responsibilities borne by the Member States as rapporteur in the evaluation and assessment, it should be possible to replace the Member State originally designated as rapporteur for a particular active substance by another Member State. |
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(22) |
To ensure the proper resourcing of this stage of the programme of work, a fee should be paid to the Member States for the handling and evaluation of dossiers and draft assessment reports. |
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(23) |
The EFSA has been consulted on the proposed measures. |
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(24) |
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
HAS ADOPTED THIS REGULATION:
CHAPTER I
SUBJECT MATTER AND SCOPE, DEFINITIONS AND THE DESIGNATED MEMBER STATE AUTHORITY
Article 1
Subject matter and scope
1. This Regulation lays down:
(a) further detailed rules for the implementation of the fourth stage of the programme of work referred to in the second subparagraph of Article 8(2) of Directive 91/414/EEC (the programme of work) with respect to the continued evaluation of the active substances notified under Regulation (EC) No 1112/2002;
(b) rules covering the active substances that were on the market before 1 May 2004 in the Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and Slovakia and which are not included in stages one to three of the programme of work and which are not covered by Regulation (EC) No 1112/2002.
2. Article 6(2) and (3) and the second paragraph of Article 6(4) of Directive 91/414/EEC shall not apply to active substances listed in Annex I to this Regulation as long as the procedures provided for in this Regulation with regard to such substances have not been finalised.
3. This Regulation shall apply without prejudice to:
(a) reviews by Member States of active substances listed in Annex I to this Regulation in particular pursuant to renewals of authorisations in accordance with Article 4(4) of Directive 91/414/EEC;
(b) reviews by the Commission in accordance with Article 5(5) of Directive 91/414/EEC;
(c) assessments carried out under Directive 79/117/EEC.
Article 2
Definitions
For the purpose of this Regulation, the definitions set out in Article 2 of Directive 91/414/EEC and Article 2 of Regulation (EC) No 1112/2002 shall apply.
The following definitions shall also apply:
(a) ‘notifier’ means the natural or legal person who has submitted a notification in accordance with:
(i) Regulation (EC) No 1112/2002, as listed in Annex II to this Regulation, or
(ii) Article 4 of this Regulation;
(b) ‘rapporteur Member State’ means the rapporteur Member State for the active substance as set out in Annex I;
(c) ‘summary dossier’ means a dossier containing the information required under Article 10(2), where summaries are given of the results of the tests and studies referred to in that paragraph;
(d) ‘complete dossier’ means a dossier containing the information required under Article 10(3), where the results of the tests and study reports referred to in the summary dossier are given in full.
Article 3
Designated Member State authority
1. Each Member State shall designate an authority or authorities to carry out the obligations of the Member States as defined in this Regulation.
2. The national authorities listed in Annex III shall coordinate and ensure all necessary contacts with notifiers, other Member States, the Commission and the European Food Safety Authority (EFSA) in accordance with this Regulation.
Each Member State shall give the details concerning the designated coordinating national authority to the Commission, the EFSA and the designated coordinating national authority of each other Member State and inform them of any modifications thereof.
CHAPTER II
NOTIFICATIONS BY PRODUCERS IN NEW MEMBER STATES OF ACTIVE SUBSTANCES
Article 4
Notifications by producers in new Member States
1. Any producer in a new Member State referred to in Article 1(1)(b) of this Regulation wishing to secure the inclusion in Annex I to Directive 91/414/EEC of an active substance listed in Annex I to this Regulation shall notify the details set out in Annex V of this Regulation to the Commission, other notifiers for that substance and the rapporteur Member State at the latest three months from the date of entry into force of this Regulation.
2. Any producer making a notification under paragraph 1 shall fulfil the obligations of producers or notifiers set out in this Regulation for the active substance notified.
3. Where a producer in a new Member State has not submitted a notification for an active substance listed in Annex I to this Regulation, in accordance with paragraph 1, it shall only be permitted to participate in the programme of work collectively with one or more notifiers of the active substance, including a Member State which has notified in accordance with paragraph 4 of this Article.
4. Where no notification has been received for an active substance listed in Annex I to this Regulation, a new Member State may declare its interest in supporting the inclusion of that active substance in Annex I to Directive 91/414/EEC by notifying the Commission and the rapporteur Member State.
That notification must be submitted as soon as possible, and no later than three months from the date the Commission has informed the Member States that no notification has been submitted for that active substance.
A Member State submitting such a notification shall thereafter be treated as the producer for the purposes of the evaluation of the active substance concerned.
5. The Commission shall decide, as provided for in the fourth subparagraph of Article 8(2) of Directive 91/414/EEC, not to include in Annex I to that Directive active substances referred to in Annex I to this Regulation for which no notification has been submitted in accordance with paragraphs 1 or 4 of this Article. The Decision shall state the reasons for the non-inclusion.
Member States shall withdraw authorisations of plant protection products containing such active substances within the period prescribed in the Decision.
CHAPTER III
CONDITIONS FOR THE SUBMISSION OF DOSSIERS OF ACTIVE SUBSTANCES AND SUBMISSION OF INFORMATION BY THIRD PARTIES
Article 5
Submission of dossiers by more than one notifier
1. Where for any active substance listed in Annex I there is more than one notifier, the notifiers concerned shall take all reasonable steps to submit the dossier for such substance collectively.
Where the dossier is not submitted by all such notifiers, it shall contain details of the efforts made and the reasons why certain notifiers have not participated in the submission of the dossier.
2. Where an active substance has been notified by more than one notifier, those notifiers shall, for each study involving vertebrate animals, give details of the attempts made to avoid duplication of testing and give, if applicable, the reasons for conducting a duplicate study.
Article 6
Submission of dossiers to the rapporteur Member State
1. The notifier shall submit the dossier for the active substance (the dossier) to the rapporteur Member State.
2. The dossier shall include the following:
(a) a copy of the notification; in the case of a collective notification made by more than one producer as referred to in Article 5(1), it shall include:
(i) a copy of the notifications made in accordance with Article 4 or 5 of Regulation (EC) No 1112/2002 or Article 4 of this Regulation;
(ii) the name of the person designated by the producers concerned as being responsible for the collective notification who will act as a contact point during the procedure;
(b) a limited range of representative uses of the active substance, in respect of which the data submitted by the notifier in the dossier shall demonstrate that for one or more preparations, the requirements set out in Article 5 of Directive 91/414/EEC for inclusion of the active substance in Annex I to that Directive may be met.
3. When requested by the rapporteur Member State as provided for in Article 20(2) to circulate the updated summary dossier or where relevant the updated complete dossier or parts thereof the notifier shall do this at the latest one month from the date of receipt of such a request.
Article 7
Dossiers for active substances submitted under Directive 98/8/EC
By derogation from Articles 5 and 6, where an active substance has been notified under Directive 98/8/EC the notifier may submit:
(a) a copy of the dossier submitted under Directive 98/8/EC;
(b) any additional information referred to in Annexes II and III to Directive 91/414/EEC necessary to justify the inclusion of the active substance in Annex I to that Directive by reference to uses falling within the scope of that Directive.
Article 8
Dossiers for active substances submitted under Regulation (EC) No 1490/2002
Where a dossier has been submitted under Regulation (EC) No 1490/2002, the person who submitted that dossier may submit, together with the further dossier submitted under this Regulation:
(a) a reference to the dossier submitted under Regulation (EC) No 1490/2002;
(b) any additional information referred to in Annexes II and III to Directive 91/414/EEC necessary to justify the inclusion of the active substance in Annex I to that Directive by reference to uses falling within the scope of this Regulation.
Article 9
Specific conditions for submissions of dossiers for active substances listed in Part A of Annex I
1. Where the dossier concerns an active substance listed in Part A of Annex I, in addition to the information required under Article 5 and Article 6(2), the notifier shall submit the following information concerning the active substance and the plant protection product (where applicable):
(a) all available information on possible risks to human and animal health and the environment including that available from searching the literature and identifying the data bases searched and search terms used;
(b) available assessment reports from any OECD country;
(c) for any ongoing tests and studies not yet fully completed, information on those tests and studies and a projected date of completion.
2. The dossier shall physically contain the individual test and study reports containing all the information referred to in paragraph 1.
3. Each Member State shall specify the number of copies of the dossier to be submitted by the notifier when it is acting as a rapporteur and when it receives copies under Article 20(2).
The format of the dossier shall take account of the recommendations made in accordance with the procedure referred to in Article 19 of Directive 91/414/EEC.
Article 10
Specific conditions for submissions of dossiers for active substances listed in Parts B to G of Annex I
1. Where the dossier concerns an active substance listed in Part B to G of Annex I, the notifier shall submit a dossier and a summary dossier.
2. The notifier(s) shall include in the summarydossier:
(a) the information required under Article 5 and Article 6(2) of this Regulation;
(b) for each point of Annex II (Part A or Part B as appropriate) to Directive 91/414/EEC and for each point of Annex III (Part A or Part B as appropriate) to that Directive, the summaries and results of tests and studies and the name of the person or institute that has carried out those tests and studies;
(c) a checklist to be filled in by the notifier, demonstrating that the dossier is complete in accordance with Article 18 of this Regulation.
The tests and studies as referred to in paragraph 2(b) of this Article shall be those relevant to the assessment of the criteria referred to in Article 5 of Directive 91/414/EEC for one or more preparations for the uses taking into account the fact that data gaps in the dossier as regards the information required under Annex II of Directive 91/414/EEC, resulting from the proposed limited range of representative uses of the active substance, may lead to restrictions in the inclusion in Annex I of Directive 91/414/EEC.
3. The complete dossier shall physically contain the individual test and study reports concerning all the information referred to in point (b) and the second subparagraph of paragraph 2.
4. Each Member State shall specify the number of copies and the format of the summary and the complete dossiers to be submitted by the notifiers.
In defining the format of the complete and summary dossiers Member States shall take account of the recommendations made in accordance with the procedure referred to in Article 19 of Directive 91/414/EEC.
Article 11
Submission of information by third parties
Any natural or legal person wishing to submit relevant information which may contribute to the evaluation of an active substance listed in Annex I, in particular with regard to the potentially dangerous effects of that substance or its residues on human and animal health and on the environment, shall do so by the relevant time limit set out in Article 12.
Such information shall be submitted to the rapporteur Member State and the EFSA. When requested by the rapporteur Member State such person shall also submit that information to the other Member States at the latest one month from the date of receipt of such a request.
Article 12
Time limits for submission of dossiers
The notifier(s) shall submit the dossier to the relevant rapporteur Member State by:
(a) 30 June 2005 at the latest for the active substances listed in Part A of Annex I;
(b) 30 November 2005 at the latest for the active substances listed in Parts B to G of Annex I.
Article 13
Non-submission of dossiers
1. Where the notifier does not submit the dossier or any part thereof within the relevant time limit set out in Article 12, the rapporteur Member State shall inform the Commission and the EFSA within two months of the date of expiry of the time limit, giving any justification for the delay provided by the notifiers.
2. On the basis of the information submitted by the rapporteur Member State in accordance with paragraph 1, the Commission shall determine whether the notifier has demonstrated that the delay in the submission of the dossier was caused by force majeure.
In that case, it shall establish a new time limit for the submission of a dossier fulfilling the relevant requirements of Articles 5, 6, 9, and 10 of this Regulation in accordance with the procedure referred to in Article 19 of Directive 91/414/EEC.
3. The Commission shall decide, as provided for in the fourth subparagraph of Article 8(2) of Directive 91/414/EEC, not to include in Annex I to that Directive an active substance for which no dossier has been submitted within the time limit provided for in Article 12 of this Regulation or the second subparagraph of paragraph 2 of this Article. The Decision shall state the reasons for the non-inclusion.
Member States shall withdraw authorisations of plant protection products containing such active substances within the period prescribed in the Decision.
Article 14
Replacement or withdrawal of notifier
1. If a notifier decides to end its participation in the programme of work for an active substance, it shall immediately inform the rapporteur Member State, the Commission, the EFSA and all other notifiers of the active substance concerned of its decision, giving the reasons.
Where a notifier ends its participation or fails to fulfil its obligations under this Regulation, the procedures provided for in Articles 15 to 24 shall be terminated as regards its dossier.
2. If a notifier agrees with another producer that the notifier shall be replaced for the purposes of further participation in the programme of work under this Regulation, the notifier and such other producer shall inform the rapporteur Member State, the Commission and the EFSA by a common declaration agreeing that such other producer shall replace the original notifier in carrying out the notifier’s duties pursuant to the relevant provisions of Articles 4, 5, 6, 9, 10, 12 and 24. They shall ensure that the other notifiers for the substance concerned are informed at the same time.
The other producer in this case shall be jointly liable with the original notifier for any fees remaining payable in relation to the notifier's application under the regime established by Member States pursuant to Article 30.
3. If all notifiers for an active substance end their participation in the programme of work a Member State may choose to act as notifier for the purposes of further participation in the programme of work.
Any Member State wishing to act as a notifier shall inform the rapporteur Member State, the Commission and the EFSA at the latest one month from the date of being informed that all notifiers have decided to end their participation and shall replace the original notifier in carrying out the notifier’s duties pursuant to the relevant provisions of Articles 4, 5, 6, 9, 10, 12 and 24.
4. All information submitted shall remain available to the rapporteur Member States, the Commission and EFSA
CHAPTER IV
EVALUATIONS OF DOSSIERS
Article 15
General Conditions for evaluations of dossiers
1. Without prejudice to Article 18 the rapporteur Member State shall evaluate all dossiers submitted to it.
2. Without prejudice to Article 7 of Directive 91/414/EEC, the rapporteur Member State shall not accept the submission of new studies during the evaluation except as provided for in Article 9 (1)(c) of this Regulation.
However, the rapporteur Member State may request the notifier to submit further data which are necessary to clarify the dossier. When doing so the rapporteur Member State shall set a time limit within which the information shall be provided. The time limit shall not affect the time limit for the submission of the draft assessment report by the rapporteur Member State to the EFSA as provided for in Article 21(1) or Article 22(1).
3. The rapporteur Member State may, from the start of the evaluation of the dossier:
(a) consult with experts from the EFSA;
(b) request additional technical or scientific information from other Member States to assist in the evaluation.
4. Notifiers may seek specific advice from the rapporteur Member State.
Article 16
Cooperation between Member States
1. The rapporteur Member States shall cooperate in the evaluation within each group set out in Annex I and shall organise such cooperation in the most effective and efficient way.
2. The rapporteur Member State identified within each group in Annex I as the ‘lead rapporteur’ shall take a lead in organising that cooperation and in organising the provision of advice to notifiers where it concerns matters of general interest to the other Member States concerned.
Article 17
Specific condition for evaluations of active substances listed in Part A of Annex I
Where possible and where it does not affect the time limit for the submission of the draft assessment report as provided for in Article 21(1), the rapporteur Member State shall evaluate further information identified under Article 9(1)(c) subsequently provided by the notifier.
Article 18
Completeness check of dossiers for substances listed in Parts B to G of Annex I
1. The rapporteur Member State shall assess the checklists provided by the notifiers in accordance with Article 10(2)(c).
2. The rapporteur Member State shall at the latest three months from the date of receipt of all dossiers for an active substance report to the Commission on the completeness of the dossiers.
3. For those active substances for which one or more dossiers are considered to be complete, the rapporteur Member State shall perform the evaluation as referred to in Articles 15 and 19, unless the Commission informs the rapporteur Member State, within two months of the date of receipt of the report of the rapporteur Member State on completeness, that it does not consider the dossier to be complete.
4. For those active substances for which a rapporteur Member State or the Commission consider that no dossier is complete within the meaning of Articles 5, 6 and 10, the Commission shall, within three months from the date of the receipt of the report of the rapporteur Member State on completeness, refer such a report to the Standing Committee for the Food Chain and Animal Health.
In accordance with the procedure referred to in Article 19 of Directive 91/414/EEC it shall be decided whether a dossier is to be considered complete within the meaning of Articles 5, 6 and 10.
5. The Commission shall decide, as provided for in the fourth subparagraph of Article 8 (2) of Directive 91/414/EEC, not to include in Annex I to Directive 91/414/EEC an active substance for which no complete dossier has been submitted within the time limit provided for in Article 12 of this Regulation or the second sub-paragraph of Article 13 (2).
Article 19
Specific conditions for evaluations of dossiers for substances listed in Parts B to G of Annex I
1. Where active substances listed in Part D of Annex I to this Regulation have been evaluated under Directive 98/8/EC those evaluations shall be taken into account, where relevant, for the purposes of this Regulation
2. Where active substances have been evaluated under a former stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC those evaluations shall be taken into account, where relevant, for the purposes of this Regulation.
3. The rapporteur Member State shall evaluate and report only on those active substances for which at least one dossier has been determined to be complete in accordance with Articles 5, 6, and 10. For dossiers concerning the same active substance not determined to be complete, it shall check whether the identity and impurities of the active substance in those dossiers are comparable to the identity and impurities of the active substance in the dossiers considered complete. It shall record its views on this point in the draft assessment report.
The rapporteur Member State shall take into consideration the information available on potentially dangerous effects in the other dossiers submitted by any notifier or by any third party in accordance with Article 11.
Article 20
General conditions for draft Assessment Reports
1. The draft assessment report shall be submitted as far as possible in the format recommended in accordance with the procedure referred to in Article 19 of Directive 91/414/EEC.
2. The rapporteur Member State shall request the notifiers to submit an updated summary dossier to the EFSA, the other Member States and on request to the Commission at the same time as the rapporteur's draft assessment report is sent to the EFSA.
The Member States, the Commission or the EFSA may request through the rapporteur Member State that notifiers also send them an updated complete dossier or parts thereof. The notifier shall provide any such updated dossier by the date specified in the request.
Article 21
Specific conditions for draft Assessment Reports and Recommendations to the Commission for active substances listed in Part A of Annex I
1. The rapporteur Member State shall send the draft assessment report to the EFSA as quickly as possible, and 12 months from the date of expiry of the time limit provided for in Article 12(a) at the latest.
2. The rapporteur Member State shall include in the draft assessment report a reference to each test or study concerning each point of Annex II (Part A or Part B as appropriate) to Directive 91/414/EEC and for each point of Annex III (Part A or Part B as appropriate) to that Directive relied on for the assessment.
That reference shall be made in the form of a list of test and study reports including the title, the author(s), the date of the study or test report and the date of publication, the standard to which the test or study was conducted, the holder’s name, and if any, the claim made by the holder or notifier for data protection.
3. At the same time as the rapporteur Member State sends its assessment report to the EFSA as provided for in paragraph 1, it shall make a recommendation to the Commission:
(a) either to include the active substance in Annex I to Directive 91/414/EEC stating where appropriate the proposed conditions for inclusion; such conditions:
(i) may include the time limit for such inclusion;
(ii) shall state whether any information is required, whether such additional information is included in the tests and studies referred to in Article 9(1)(c) of this Regulation and if so, the probable timetable for the provision of such information; or
(b) not to include the active substance in Annex I to Directive 91/414/EEC, stating the proposed reasons for the non-inclusion.
4. In addition to the conditions for inclusion proposed under paragraph 2(a) of this Article, the rapporteur Member State may indicate if it has identified, for the proposed limited range of representative uses mentioned in the dossier, any information missing from the dossier which may be required by Member States as confirmatory information when they come to grant authorisations under Article 4 of Directive 91/414/EEC for plant protection products containing that active substance.
Article 22
Specific conditions for draft Assessment Reports and Recommendations to the Commission for active substances listed in Parts B to G of Annex I
1. The rapporteur Member State shall send a draft assessment report to the EFSA as quickly as possible, and at the latest 12 months from the date the dossier was determined to be complete in accordance with Article 18(2).
2. The rapporteur Member State shall include in the draft assessment report a reference to each test or study concerning each point of Annex II (Part A or Part B as appropriate) to Directive 91/414/EEC and for each point of Annex III (Part A or Part B as appropriate) to that Directive relied on for the assessment.
That reference shall be made in the form of a list of test and study reports including the title, the author(s), the date of the study or test report and the date of publication, the standard to which the test or study was conducted, the holder’s name and, if any, the claim made by the holder or notifier for data protection.
3. At the same time as the rapporteur Member State sends its assessment report to the EFSA as provided for in paragraph 1, it shall make a recommendation to the Commission:
(a) either to include the active substance in Annex I to Directive 91/414/EEC, stating the reasons for the inclusion;
(b) or not to include the active substance in Annex I to Directive 91/414/EEC, stating the reasons for the non-inclusion.
Article 23
Replacement of rapporteur Member State
1. A rapporteur Member State shall inform the Commission and the EFSA as soon as it becomes clear that it will be unable to comply with the time limits set out in Articles 21(1) and 22(1) for the submission of the draft assessment report to the EFSA and give the reasons for the delay.
2. It may be decided to replace a rapporteur Member State for a particular active substance by another Member State where:
(a) during the assessment and evaluation provided for in Articles 15, 16, 17 and 19 it becomes apparent that there is an imbalance in the responsibilities borne and the work to be done or actually done by the Member States as rapporteurs; or
(b) it is clear that a Member State is unable to fulfil its obligations under this Regulation.
Such replacement shall be decided in accordance with the procedure referred to in Article 19 of Directive 91/414/EEC.
3. Where it has been decided to replace a rapporteur Member State the original rapporteur Member State shall immediately after such a decision has been taken inform the notifiers concerned and shall transfer to the newly designated rapporteur Member State all correspondence and information which it has received as rapporteur Member State for the active substance concerned.
The original Member State shall return to the notifier the part of the fee referred to in Article 30 which has not been used. The newly designated rapporteur Member State may require the payment of a further fee in accordance with Article 30.
Article 24
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.
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 ►M3 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) ( 10 )
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 |
|
▼M1 ————— |
||
|
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 |
|
|
▼M1 ————— |
||
|
Milk albumin |
Czech Republic |
|
|
▼M1 ————— |
||
|
Urea (see also Group 6.2.) |
Greece |
FOC-GB OMX-GB |
|
▼M1 ————— |
||
|
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 |
|
▼M1 ————— |
||
|
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 |
|
▼M1 ————— |
||
|
Mustard powder |
Latvia |
|
|
Pepper Notified as repellant |
United Kingdom |
BOO-GB PBI-GB |
|
▼M1 ————— |
||
|
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 |
|
▼M1 ————— |
||
|
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 |
|
▼M1 ————— |
||
|
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 |
|
▼M1 ————— |
||
|
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 |
|
|
▼M1 ————— |
||
|
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) |
|
▼M1 ————— |
||
|
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 |
|
|
▼M1 ————— |
||
|
(Z,Z,Z,Z)-7,13,16,19-Docosatetraen-1-yl isobutyrate |
SHC-FR |
|
|
1,4-Diaminobutane (Putrescine) |
Austria |
LLC-AT |
|
▼M1 ————— |
||
|
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) |
||
|
▼M1 ————— |
||
|
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) |
||
|
▼M1 ————— |
||
|
2-Methyl-6-methylene-7-octen-4-ol (Ipsenol) |
||
|
3-Methyl-3-buten-1-ol |
||
|
▼M1 ————— |
||
|
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 |
|
▼M1 ————— |
||
|
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 |
|
|
▼M1 ————— |
||
|
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
|
Code identification |
Name |
Address |
|
ABB-GB |
Activa/Babolna Bromadiolone Task Force |
8 Cabbage MoorGreat ShelfordCambridge CB2 5NBUnited KingdomTel. (44-1223) 84 04 89Fax (44-1223) 84 04 89hancock@chemregservs.co.uk |
|
ABC-GB |
AgriSense-BCS Ltd |
Treforest Industrial EstatePontypriddMid Glamorgan CF37 5SUUnited KingdomTel. (44-1443) 84 11 55Fax (44-1443) 84 11 52mail@agrisense.demon.co.uk |
|
ABP-DE |
Agrinova GmbH |
Hauptstraße 13D-67283 Obrigheim/MühlheimTel.: (49) 6359 32 14Fax: (49) 6359 32 14agrinova@t-online.de |
|
ACI-BE |
Agriculture Chimie Industrie International |
Avenue Albert 233B-1190 BruxellesTéléphone (32-2) 508 10 93Télécopieur (32-2) 514 06 32roland.levy@swing.be |
|
ACP-FR |
Action Pin |
ZI de CazalieuBP 30F-40260 Castets des LandesTéléphone (33) 558 55 07 00Télécopieur (33) 558 55 07 07actionpin@action-pin.fr |
|
ADC-DE |
ADC Agricultural Development Consulting |
Am Vilser Holz 17D-27305 Bruchhausen-VilsenTel.: (49) 4252-27 81Fax: (49) 4252-35 98stratmannb@adc-eu.com |
|
AGB-IT |
Agribiotec srl |
Via San Bernardo, 22I-26100 CremonaTel. (39) 0535 467 02Fax (39) 0535 591 95paolo.lameri@agribiotec.com |
|
AGC-FR |
Agrimer |
BP 29Prat MenanF-29880 PlouguerneauTéléphone (33) 298 04 54 11Télécopieur (33) 298 04 55 15fnicolas@agrimer.com |
|
AGE-IT |
Agrivet S.a.s. di Martinelli Maurizio & C. |
Via S. Giovanni, 6050I-40024 Castel San Pietro (BO)Tel. (39) 051 94 91 19Fax (39) 051 615 31 85r.martinelli@bo.nettuno.it |
|
AGF-IT |
Agrifutur srl |
Agrifutur srlVia Campagnole, 8I-25020 Alfianello (Brescia)Tel. (39) 030 993 47 76Fax (39) 030 993 47 77rkm@numerica.it |
|
AGI-IT |
Agrimix s.r.l. |
Viale Città d'Europa 681I-00144 RomaTel. (39) 06 529 62 21Fax (39) 06 529 14 22info@agrimix.com |
|
AGL-GB |
Agil Ltd |
Hercules 2, Calleva ParkAldermastonReading RG7 8DNUnited KingdomTel. (44-118) 981 33 33Fax (44-118) 981 09 09murray@agil.com |
|
AGN-IT |
Zolfindustria Srl |
Via Cantarana, 17I-27043 San Cipriano Po (PV)Tel. (39) 0385 24 17 00Fax (39) 0385 24 17 05agrindustria.srl@tin.it |
|
AGR-ES |
Agrichem, SA |
Plaza de Castilla, 3, 14AE-28046 MadridTel. (34) 913 14 98 88Fax (34) 913 14 98 87info@agrichembio.com |
|
AIF-IT |
Aifar Agricola SRL |
Registration DepartmentVia Bazzano 12I-16019 Ronco Scrivia (GE)Tel. (39) 010 935 02 67Fax (39) 010 935 05 32posta@aifar.it |
|
ALF-ES |
Alfarin Química SA |
Ibiza 35, 5oCE-28009 MadridTel. (34) 915 74 87 07Fax (34) 915 04 31 59alfarin@asertel.es |
|
ALT-FR |
Alltech France |
EU Regulatory Affairs Department2-4 avenue du 6 juin 1944F-95190 GoussainvilleTéléphone (33) 134 38 98 98Télécopieur (33) 134 38 98 99gbertin@alltech.com |
|
AMI-IT |
Aminco Srl |
Via Mandilli 14I-12071 Bagnasco (Cn)Tel. (39) 0174 71 66 06Fax (39) 0174 71 39 63aminco@isiline.it |
|
AMU-DE |
Amu-Systeme |
Büschem 13D-53940 HellenthalTel.: (49) 2482 10 24Fax: (49) 2482 70 89amu-hellenthal@t-online.de |
|
AMV-GB |
Amvac Chemical UK LTD |
Surrey Technology Centre40 Occam RdThe Surrey Research ParkGuildford GU2 7YGUnited KingdomTel. (44-1483) 29 57 80Fax (44-1483) 28 57 81amvacat@easynet.co.uk |
|
APT-GB |
Activa/PelGar Brodifacoum and Difenacoum task Force |
8 Cabbage MoorGreat ShelfordCambridge CB2 5NBUnited KingdomTel. (44-1223) 84 04 89Fax (44-1223) 84 04 89hancock@chemregservs.co.uk |
|
ARC-NL |
Arcadis PlanRealisatie B.V. |
Tree ServicesMarowijne 80NL-7333 PJ ApeldoornTel.: (31-55) 599 94 44Fax: (31-55) 533 88 44r.valk@arcadis.nl |
|
ASF-IT |
Asfaleia SRL. |
Via Mameli, 6I-06124 PerugiaTel. (39) 075 573 49 35Fax (39) 017 82 25 26 32postmaster@asfaleia.it |
|
ASP-NL |
Asepta B.V. |
PO Box 33Cyclotronweg 1NL-2600 AA DelftTel.: (31-15) 256 92 10Fax: (31-15) 257 19 01a.vandenende@asepta.nl |
|
ASU-DE |
Stähler Agrochemie GmbH & Co. KG |
Stader ElbstraßeD-21683 StadeTel.: (49) 4141 92 040Fax: (49) 4141 92 0410staehler-agro@staehler.com |
|
AVA-AT |
Avenarius-Agro GmbH |
Industriestraße 51A-4600 WelsTel.: (43) 7242-489-0Fax: (43) 7242-489-5d.stroh@avenarius-agro.at |
|
BAR-GB |
Barrier Biotech Limited |
36 Haverscroft Ind. Est.New RoadAttleborough Norfolk NR17 1YEUnited KingdomTel. (44-1953) 45 63 63Fax (44-1953) 45 55 94nigelb@barrier-biotech.com |
|
BAS-DE |
BASF Aktiengesellschaft |
APT/EQM — V 005D-67056 LudwigshafenTel.: (49) 621 607 90 26Fax: (49) 621 605 20 40siegfried.kersten@basf-ag.de |
|
BBI-SE |
Binab Bio-Innovation AB |
Florettgatan 5S-254 67 HelsingborgTfn (46-42) 16 37 04Fax (46-42) 16 24 97info@binab.se |
|
BCH-DE |
Bayer/Dow Task Force via Bayer AG, Bayer Chemicals |
D-51368 LeverkusenTel.: (49) 214 306 22 68Fax: (49) 214 307 23 39klaus.stroech.ks@bayerchemicals.com |
|
BAL-IE |
BioAtlantis Ltd |
Baylands, BallyardTraleeCounty KerryIrelandTel. (353-66) 71-28592Fax (353-66) 711 98 02jtostralee@eircom.net |
|
BCP-GB |
Biological Crop Protection Ltd |
Occupation Road, WyeAshford TN25 5ENUnited KingdomTel. (44-1233) 81 32 40Fax (44-1233) 81 33 83richardc@biological-crop-protection.co.uk |
|
BCS-DE |
Bayer CropScience AG |
Alfred-Nobel-Straße 50D-40789 Monheim am RheinTel.: (49) 2173 38 33 63Fax: (49) 2173 38 49 27norbert.hesse@bayercropscience.com |
|
BCS-FR |
Bayer CropScience SA |
14-20 rue Pierre BaizetBP 9163F-69263 Lyon Cedex 09Téléphone (33) 472 85 25 25Télécopieur (33) 472 85 30 82martyn.griffiths@bayercropscience.com |
|
BIB-ES |
Bioibérica, SA |
Polígono Industrial Mas PuigvertCtra. N-II Km. 680,6E-08389 Palafolls, BarcelonaTel. (34) 937 65 03 90Fax (34) 937 65 01 02ibartoli@bioiberica.com |
|
BNG-IE |
Brown & Gillmer LTD. |
Florence Lodge199 Strand Road, MerrionDublin 4IrelandTel. (353-1) 283 82 16Fax (353-1) 269 58 62bgfeeds@indigo.ie |
|
BOB-DK |
Borregaard BioPlant ApS |
Helsingforsgade 27 BDK-8200 Århus NTlf. (45) 86 78 69 88Fax (45) 86 78 69 22borregaard@bioplant.dk |
|
BOO-GB |
Bootman Chemical Safety Ltd. |
Diss Business CentreDiss IP21 4HDUnited KingdomTel. (44-1379) 64 05 34Fax (44-1379) 64 08 35info@bootmanchem.com |
|
BPO-GB |
BP Global Special Products Ltd |
Witan Gate House500-600 Witan GateMilton Keynes MK9 1ESUnited KingdomTel. (44-1908) 85 33 44Fax (44-1908) 85 38 96gspinfo@bp.com |
|
BRA-GB |
BRA-Europe |
33 Khattoun RoadTooting BroadwayLondon SW17 OJAUnited KingdomTel. (44-208) 378 05 17Fax (44-208) 378 05 17braeurope@aol.com |
|
BRI-GB |
Brimac Carbon Services |
21 Dellingburn StreetGreenock PA15 4TPUnited KingdomTel. (44-1475) 72 02 73Fax (44-1475) 72 00 16info@brimacservices.com |
|
BRM-GB |
BRM Agencies |
Cheshire House164 Main RoadGoostrey CW4 8JPUnited KingdomTel. (44-1477) 54 40 52Fax (44-1477) 53 71 70brianmartin@cheshirehouse.co.uk |
|
CAL-FR |
Calliope SAS |
Route d'ArtixBP 80F-64150 NoguèresTéléphone (33) 559 60 92 92Télécopieur (33) 559 60 92 19fleconte@calliope-sa.com |
|
CAP-FR |
Capiscol |
160 route de la ValentineF-13011 MarseilleTéléphone (33) 491 24 45 45Télécopieur (33) 491 24 46 11anne.coutelle@capiscol.com |
|
CAT-PT |
Cafum |
Centro Agro Técnico de Fumigações Lda.Rua de Moçambique 159 A2PT-3000 CoimbraTel.: (351-239) 40 10 60 ou (351-239) 40 59 70Fax: (351-239) 70 43 76cafum@cafum.pt |
|
CEL-DE |
Scotts Celaflor GmbH |
Konrad-Adenauer-Straße 30D-55218 IngelheimTel.: (49) 6132 78 03-0Fax: (49) 6132 20 67otto.schweinsberg@scotts.com |
|
CEQ-ES |
Cequisa |
Muntaner, 322, 1oE-08021 BarcelonaTel. (34) 932 40 29 10Fax (34) 932 00 56 48xavier@cequisa.com |
|
CER-FR |
Cerexagri SA |
1 rue des Frères LumièreF-78373 PlaisirTéléphone (33) 130 81 73 00Télecopieur (33) 130 81 72 50mark.egsmose@cerexagri.com |
|
CFP-FR |
Nufarm SA |
Département ‘Homologations et Règlementation’28 boulevard CamélinatF-92230 GennevilliersTéléphone (33) 140 85 50 20Télecopieur (33) 140 85 51 56claude.chelle@fr.nufarm.com |
|
CFW-DE |
Chemische Fabrik Wülfel GmbH & Co. KG |
Hildesheimer Straße 305D-30519 HannoverTel.: (49) 511 984 96-0Fax: (49) 511 984 96-40cfw@wuelfel.de |
|
CGL-GB |
Catalytic Generators UK Limited |
Mariel T Monk2 Priory Court Pilgrim StreetLondonUnited KingdomTel. (44-207) 236 14 14Fax (44-207) 329 87 87london@merricks.co.uk |
|
CHE-DK |
Cheminova A/S |
Registration DepartmentP.O. Box 9DK-7620 LemvigTel. (45) 96 90 96 90Fax (45) 96 90 96 91info@cheminova.dk |
|
CHM-FR |
Chemimpex SA/Mauer |
1817 Route de TutegnyF-01170 CessyTéléphone (33) 450 41 48 60amselian@aol.com |
|
CLM-NL |
CLM research and advice Plc |
PO Box 10015Amsterdamsestraatweg 877NL-3505 AA UtrechtTel.: (31-30) 244 13 01Fax: (31-30) 244 13 18clm@clm.nl |
|
CNA-ES |
Carus Nalon SL |
Barrio Nalon s/nE-33100 Trubia/OviedoTel. (34) 985 78 55 13Fax (34) 985 78 55 10carus@carusnalon.com |
|
COL-FR |
Coleacp |
5 rue de la CorderieCENTRA 342F-94586 Rungis CedexTéléphone (33) 141 80 02 10Télécopieur (33) 141 80 02 19coleacp@coleacp.org |
|
CPS-ES |
Cepsa |
Av. Partenón, 12Campo de las NacionesE-28042 MadridTel. (34) 913 37 96 69Fax (34) 913 37 96 09aranzazu.guzman@madrid.cepsa.es |
|
CRO-GB |
Crompton Europe Limited |
Kennet House4 Langley Quay, LangleySlough SL3 6EHUnited KingdomTel. (44-1753) 60 30 48Fax (44-1753) 60 30 77phil.pritchard@cromptoncorp.com |
|
CRT-GB |
Certis |
1b Mills WayBoscombe Bown Business ParkAmesbury SP4 7RXUnited KingdomTel. (44-1980) 67 65 00Fax (44-1980) 62 65 55certis@certiseurope.co.uk |
|
CRU-IT |
Cerrus sas |
Via Papa Giovanni XXIII, 84I-21040 Uboldo (VA)Tel. (39) 02 96 78 21 08Fax (39) 02 96 78 29 01cerrus@tiscalinet.it |
|
PZD-NL |
Plantenziektenkundige Dienst |
PO Box 9102NL-6700 HC WageningenTel.: (31-31) 749 69 11Fax: (31-31) 742 17 01p.jellema@pd.agro.nl |
|
CVX-BE |
ChevronTexaco Technology Ghent |
Technologiepark — Zwijnaarde 2B-9052 Gent/ZwijnaardeTel. (32) 9 240 71 11Fax (32) 9 240 72 22arickjl@chevrontexaco.com |
|
DEN-NL |
DeruNed bv |
Marconistraat 10NL-2665 JE BleiswijkTel.: (31-10) 522 15 14Fax: (31-10) 522 02 50deruned@deruned.nl |
|
DET-DE |
Detia Freyberg GmbH |
Dr.-Werner-Freyberg-Straße 11D-69514 LaudenbachTel.: (49) 6201 708-0Fax: (49) 6201 708-427zulassung@detia-degesch.de |
|
DKI-NL |
Denka International B.V. |
Hanzeweg 1NL-3771 NG BarneveldTel.: (31-34) 245 54 55Fax: (31-34) 249 05 87info@denka.nl |
|
DUS-DE |
Degussa Texturant Systems Deutschland GmbH & Co. KG |
Ausschläger Elbdeich 62D-20539 HamburgTel.: (49) 40 789 55-0Fax: (49) 40 789 55 83 29reception.hamburg@degussa.com |
|
DXN-DK |
Duxon ApS |
Skovgaardsvænget 628DK-8310 Tranbjerg JTlf. (45) 96 23 91 00Fax (45) 96 23 91 02duxon@mail.tele.dk |
|
ECP-DE |
Elefant Chemische Produkte GmbH |
Ringstraße 35—37D-70736 FellbachTel.: (49) 711 58 00 33Fax: (49) 711 58 00 35elefant-gmbh@web.de |
|
ECY-GB |
ECOspray Ltd |
Grange FarmCockley Cley RoadHilborough ThetfordIP26 5BTUnited KingdomTel. (44-176) 75 61 00Fax (44-176) 75 63 13enquiries@ecospray.com |
|
ERO-IT |
Euroagro s.r.l. |
via Lazzaretti 5/AI-42100 Reggio EmiliaTel. (39) 0522 51 86 86Fax (39) 0522 51 49 91euroagro_italia@libero.it |
|
ESA-NL |
ECOstyle BV |
Vaart Noordzijde 2aNL-8426 AN AppelschaTel.: (31-51) 643 21 22Fax: (31-51) 643 31 13info@ecostyle.nl |
|
ESS-IT |
Esseco SpA |
Via San Cassiano 99I-28069 Trecate (Novara)Tel. (39) 0321 790-1Fax (39) 0321 790-215chemsupport@esseco.it |
|
FBL-DE |
FiBL Berlin e.V. |
Dr. K. WilboisRungestraße 29D-10179 BerlinTel.: (49) 6257 50 54 89Fax: (49) 6257 50 54 98klaus-peter.wilbois@fibl.de |
|
FER-GB |
Feralco (UK) Limited |
Ditton RoadWidnes WA8 0PHUnited KingdomTel. (44-151) 802 29 10Fax (44-151) 802 29 99barry.lilley@feralco.com |
|
FIN-GB |
Fine Agrochemicals Ltd |
Hill End HouseWhittingtonWorcester WR5 2RQUnited KingdomTel. (44-1905) 36 18 00Fax (44-1905) 36 18 10enquire@fine-agrochemicals.com |
|
FLU-DE |
Flügel GmbH |
Westerhöfer Straße 45D-37520 Osterode/HarzTel.: (49) 5522 823 60Fax: (49) 5522 843 26info@fluegel-gmbh.de |
|
FOC-GB |
Forestry Commission |
Forestry Commission Silvan House231 Corstorphine RoadEdinburgh EH12 7ATUnited KingdomTel. (44-131) 334 03 03Fax (44-131) 334 30 47james.dewar@forestry.gsi.gov.uk |
|
FRB-BE |
Mr. John Ivey |
Les Clos des CoulerinsF-74580 ViryTéléphone (33) 450 04 76 01Télécopieur (33) 450 04 76 01JIvey94819@aol.com |
|
FRU-DE |
Frunol Delizia GmbH |
Dübener Straße 145D-04509 DelitzschTel.: (49) 34202 65 30-0Fax: (49) 34202 65 30-9info@frunol-delicia.de |
|
GER-FR |
Germicopa SAS |
1 allée Loeiz-HerrieuF-29334 Quimper CedexTéléphone (33) 298 10 01 00Télécopieur (33) 298 10 01 42jeanyves.abgrall@germicopa.fr |
|
GLO-BE |
Globachem NV |
Leeuwerweg 138B-3803 Sint-TruidenTel. (32-1) 178 57 17Fax (32-1) 168 15 65globachem@globachem.com |
|
GOB-IT |
L. Gobbi s.r.l. |
Registration DepartmentVia Vallecalda 33I-16013 Campo Ligure (GE)Tel. (39) 010 92 03 95Fax (39) 010 92 14 00info@lgobbi.it |
|
GOM-ES |
Gomensoro Química SA |
Torneros, 14Polígono Industrial Los ÁngelesE-28906 Getafe, MadridTel. (34) 916 95 24 00Fax (34) 916 82 36 99gomenki@arrakis.es |
|
GSO-GB |
Growing Success Organics Limited |
Hill Top Business ParkDevizes RoadSalisbury SP3 4UFUnited KingdomTel. (44-1722) 33 77 44Fax (44-1722) 33 31 77info@growingsucess.org.uk |
|
GTL-GB |
Growth Technology Ltd |
Unit 66, Taunton Trading EstateTaunton TA2 6RXUnited KingdomTel. (44-1823) 32 52 91Fax (44-1823) 32 54 87info@growthtechnology.com |
|
GYL-SE |
Gyllebo Gödning AB |
Vessmantorpsvägen 16S-260 70 LjungbyhedTfn (46-435) 44 10 40Fax (46-435) 44 10 40gyllebo.plantskydd@telia.com |
|
HAS-GR |
House of Agriculture Spirou Aebe |
Dr Dinos Chassapis, AssistantProfessor in Chemistry5, Markoni Str.GR-122 42 AthensΤηλ.: (30) 210-349 75 00Φαξ: (30) 210-342 85 01agrospir@spirou.gr |
|
HLA-GB |
Headland Agrochemicals Ltd |
Norfolk HouseGreat Chesterford CB10 1PFUnited KingdomTel. (44-1799) 53 01 46Fax (44-1799) 53 02 29stephen.foote@headlandgroup.com |
|
HOC-GB |
Hockley International Limited |
Hockley House354 Park LanePoynton Stockport SK12 1RLUnited KingdomTel. (44-1625) 87 85 90Fax (44-1625) 87 72 85mail@hockley.co.uk |
|
HRM-BE |
Hermoo Belgium NV |
Zepperenweg 257B-3800 Sint-TruidenTel. (32-1) 168 68 66Fax (32-1) 170 74 84hermoo@hermoo.be |
|
HTO-GB |
Tioxide Europe Ltd |
Haverton Hill RoadBillingham TS23 1PSUnited KingdomTel. (44-1642) 37 03 00Fax (44-1642) 37 02 90greg_s_mcnulty@huntsman.com |
|
IAB-ES |
IAB, SL (Investigaciones y Aplicaciones Biotecnológicas, SL) |
Ctra. Moncada-Náquera, km 1,7E-46113 Moncada (Valencia)Tel. (34) 961 30 90 24Fax (34) 961 30 92 42iab@iabiotec.com |
|
IAS-SE |
Interagro Skog AB |
EliselundS-247 92 Södra SandbyTfn (46-46) 532 00Fax (46-46) 532 08walde@interagroskog.se |
|
IBT-IT |
Intrachem Bio Italia Spa |
Via XXV Aprile 44I-24050 Grassobbio BergamoTel. (39) 035 33 53 13Fax (39) 035 33 53 34info@intrachem.it |
|
IDB-ES |
Idebio SL |
Bell, 3 — Polígono El MontalvoE-37188 Carbajosa De La SagradaSalamancaTel. (34) 92 31 92 40Fax (34) 92 31 92 39idebio@helcom.es |
|
IOI-DE |
Imperial-Oel-Import Handelsgesellschaft mbH |
Bergstraße 11D-20095 HamburgTel.: (49) 4033 85 33-0Fax: (49) 4033 85 33 85info@imperial-oel-import.de |
|
ISA-IT |
Isagro S.p.A. |
Via Caldera 2120153 MilanoTel. (39) 0240 90 11Fax (39) 0240 90 12 87agiambelli@isagro.it |
|
JAH-GB |
J A Humphrey Agriculture |
189 Castleroe RoadColeraine BT51 3QTUnited KingdomTel. (44-28) 70 86 87 33Fax (44-28) 70 86 87 35rhumphrey@nicobrand.com |
|
JCA-ES |
Julio Cabrero y Cía, SL |
Puerto De RequejadaE-39312-Requejada (Cantabria)Tel. (34) 942 82 40 89Fax (34) 942 82 50 57julio.cabrero@juliocabrero.com |
|
JEY-GB |
Jeyes Ltd |
Brunel WayThetford IP24 1HFUnited KingdomTel. (44-1842) 75 45 67Fax (44-1842) 75 76 83nigel.cooper@jeyes.co.uk |
|
JSC-GB |
JSC International Ltd |
Osborne House20 Victoria AvenueHarrogate HG1 5QYUnited KingdomTel. (44-1423) 52 02 45Fax (44-1423) 52 02 97terry.tooby@jsci.co.uk |
|
KBS-NL |
Koppert Beheer BV |
Department R&D Microbials and Regulatory AffairsVeilingweg 17/PO Box 155NL-2650 AD Berkel en RodenrijsTel.: (31-10) 514 04 44Fax: (31-10) 511 52 03info@koppert.nl |
|
KIR-NL |
Kemira Chemicals B.V. |
PO Box 1015NL-3180 AA RozenburgTel.: (31-18) 128 25 40Fax: (31-18) 128 25 36dees_van.kruyssen@kemira.com |
|
KRO-DE |
Kronos International, INC. |
Peschstraße 5D-51373 LeverkusenTel.: (49) 214 356-0Fax: (49) 214 421 50kronos.leverkusen@nli-usa.com |
|
KWZ-AT |
F. Joh. Kwizda GmbH |
Sarea SaatguttechnikFreilingerstraße 44A-4614 MarchtrenkTel.: (43) 7243 535 26-0Fax: (43) 7243 535 26-12office@sarea.at |
|
LGO-FR |
Laboratoires GOËMAR SA |
ZAC La MadeleineAvenue Général-PattonF-35400 Saint-MaloTéléphone (33) 299 21 53 70Télécopieur (33) 299 82 56 17labo@goemar.com |
|
LIP-FR |
LiphaTech SA |
201 rue CarnotF-94126 Fontenay-sous-BoisTéléphone (33) 143 94 55 50Télécopieur (33) 148 77 44 31ahoussin@merck.fr |
|
LLC-AT |
Consep GmbH |
Furth 27A-2013 GollersdorfTel.: (43) 2954 30244Fax: (43) 2954 30245wmaxwald@lander.es |
|
LON-DE |
Lonza GmbH |
Morianstraße 32D-42103 WuppertalTel.: (49) 202 245 38 33Fax: (49) 202 245 38 30gisbert.mehring@lonzagroup.com |
|
LUX-NL |
Luxan B.V. |
Industrieweg 2NL-6662 PA ElstTel.: (31-48) 136 08 11Fax: (31-48) 137 67 34luxan@luxan.nl |
|
MAK-BE |
Makhteshim-Agan International Coordination Centre (MAICC) |
Avenue Louise 283B-1050 BruxellesTéléphone (32-2) 646 86 06Télécopieur (32-2) 646 91 52steve.kozlen@maicc.be |
|
MAS-BE |
Mitsui AgriScience International SA/BV |
Boulevard de la Woluwe 60Woluwedal 60B-1200 BrusselTel.: (32-2) 331 38 94Fax: (31-2) 331 38 60thorez@certiseurope.fr |
|
MEL-NL |
Melchemie Holland B.V. |
Postbus 143NL-6800 AC ArnhemTel.: (31-26) 445 12 51Fax: (31-26) 442 50 93info@melchemie.com |
|
MEU-GB |
Mycotech Europe LTD. |
12 Lonsdale GardensTunbridge Wells TN1 1PAUnited KingdomTel. (44-1580) 88 20 59Fax (44-1580) 88 20 57fjr@agrilexuk.com |
|
MFS-GB |
Macfarlan Smith Limited |
Wheatfield RoadEdinburgh EH11 2QAUnited KingdomTel. (44-131) 337 24 34Fax (44-131) 337 98 13melanie.jackson@macsmith.com |
|
MGK-GB |
MGK Europe Limited |
21 Wilson StreetLondon EC2M 2TDUnited KingdomTel. (44-207) 588 08 00Fax (44-207) 588 05 55glazer.barry@dorseylaw.com |
|
MIB-NL |
Micro Biomentor BV |
PO Box 50Middelbroekweg 672675 ZH HonselersdijkTel.: (31-17) 462 67 63Fax: (31-17) 461 40 76info@microbiomentor.nl |
|
NDC-SE |
NIM Distribution Center AB |
Stigbergsvägen 4S-141 32 HuddingeTfn (46-8) 740 26 30Fax (46-8) 740 2618info@bionim.com |
|
NEU-DE |
W. Neudorff GmbH KG |
An der Mühle 3D-31860 EmmerthalTel.: (49) 5155 624-126Fax: (49) 5155 60 10wilhelmy@neudorff.de |
|
NLI-AT |
Nufarm GmbH & Co KG |
Registration DepartmentSt.-Peter-Straße 25A-4021 LinzTel.: (43) 732 69 18-0Fax: (43) 732 69 18-2004eric.gibert@at.nufarm.com |
|
NOV-FR |
Novance SA |
VenetteBP 20609F-60206 CompiègneTéléphone (33) 344 90 70 96Télécopieur (33) 344 90 70 70p.ravier@novance.com |
|
NSA-GB |
National Sulphuric Acid Association Limited |
19 Newgate StreetChester CH1 1DEUnited KingdomTel. (44-1244) 32 22 00Fax (44-1244) 34 51 55tomfleet@nsaa.org.uk or pamlatham@nsaa.org.uk |
|
NSC-GB |
Novigen Sciences Ltd |
2D Hornbeam Park OvalHarrogate HG2 8RBUnited KingdomTel. (44-1423) 85 32 00Fax (44-1423) 81 04 31charris@novigensci.co.uk |
|
OGT-IE |
Oilean Glas Teoranta |
MeenmoreDungloeCounty DonegalIrelandTel. (353-75) 213 19Fax (353-75) 218 07smgo11@gofree.indigo.ie |
|
OLE-BE |
Oleon nv |
Assenedestraat 2B-9940 ErtveldeTel.: (32-9) 341 10 11Fax: (32-9) 341 10 00info@oleon.com |
|
OMX-GB |
Omex Agriculture Ltd |
Bardney AirfieldTupholmeLincoln LN3 5TPUnited KingdomTel. (44-1526) 39 60 00Fax (44-1526) 39 60 01enquire@omex.com |
|
ORI-GB |
Organic Insecticides |
Parkwood, Maltmans LaneGerrards Cross SL9 8RBUnited KingdomTel. (44-1494) 81 65 75Fax (44-1494) 81 65 78 |
|
OSK-ES |
Osku España, SL |
Polígono Industrial El Zurdo, nave 13Ctra. de la EstaciónE-Abarán, MurciaTel. (34) 968 77 06 23Fax (34) 968 77 06 12oskuesp@oskuesp.e.telefonica.net |
|
PAB-SE |
Perstorp Specialty Chemicals AB |
S-284 80 PerstorpTfn (46-435) 380 00Fax (46-435) 381 00perstorp@perstorp.com |
|
PBC-ES |
Procesos Bioquímicos Claramunt-Forner, SL |
Senda de les Deu, 11E-46138 Rafelbunol, ValenciaTel. (34) 961 40 21 69Fax (34) 961 40 21 69ana.perez@acgbioconsulting.com |
|
PBI-GB |
pbi Home & Garden Ltd |
Durhan House214-224 High StreetWaltham Cross EN8 7DPUnited KingdomTel. (44-1992) 78 42 00Fax (44-1992) 78 49 50teresa.jones@pbi.co.uk |
|
PBK-AT |
Manfred Pfersich, Kenya Pyrethrum Information Centre |
Kenya Pyrethrum Information CentreHaslaustraße 807A-5411 OberalmTel.: (43) 6245 83 38 10Fax: (43) 6245 823 56manfred.pfersich@kenya-pyrethrum.com |
|
PEL-GB |
PelGar International Ltd. |
Index House, Peak CentreMidhurst RdLiphook GU30 7TNUnited KingdomTel. (44-1428) 72 22 50Fax (44-1428) 72 28 11info@pelgar.demon.co.uk |
|
PET-PT |
Petrogal, S.A. |
Rua Tomás da Fonseca, Torre CPT-1600-209 LisboaTel.: (351-21) 724 26 08Fax: (351-21) 724 29 53luis.brito.soares@galpenergia.com |
|
PGM-GB |
Pet and Garden Manufacturing plc |
Queens Rd.Sanquhar DG4 6DNUnited KingdomTel. (44-1223) 84 04 89Fax (44-1223) 84 04 89hancock@chemregservs.co.uk |
|
PHS-FR |
Physalys |
3 rue de l'Arrivée — BP 215F-75749 Paris Cedex 15Téléphone (33) 143 21 70 62Télécopieur (33) 143 21 70 63ybassat@physalys.com |
|
PHY-GR |
Phytophyl N·G· Stavrakis |
Averof 16GR-104 33 AthensΤηλ.: (30) 22620 586 70Φαξ: (30) 22620 587 35nista@otenet.gr |
|
PKA-DE |
Probis GmbH & Andermatt Biocontrol Taskforce |
Daimlerstraße 16/1D-75446 WiernheimTel.: (49) 7044 91 42 21Fax: (49) 7044 91 42 25probis.knoch@t-online.de |
|
PLS-IT |
Polisenio srl. |
Via S. Andrea 10I-48022 Lugo (RA)Tel. (39) 0545 245 60Fax (39) 0545 245 87polisenio@lamiarete.com |
|
PNP-NL |
PNP Holding bv |
Nijverheidsplein 21 GNL-3771 MR BarneveldTel.: (31-34) 240 47 60Fax: (31-34) 240 47 67info@axcentive.com |
|
PPP-FR |
Plant Protection Projects |
Le Pont NeufRoute de GordesF-84220 Cabriéres d'AvignonTéléphone (33) 432 52 17 51Télécopieur (33) 490 76 80 71stephen.shires@wanadoo.fr |
|
PRO-ES |
Probelte, SA |
Ctra. Madrid, km. 384,6 Polígono IndustrialEl TiroE-30100 Espinardo (Murcia)Tel. (34) 968 30 72 50Fax (34) 968 30 54 32probelte@probelte.es |
|
PSD-GB |
Pesticides Safety Directorate |
Mallard House, Kings Pool3 Peasholme GreenYork YO1 7PXUnited KingdomTel. (44-1904) 64 05 00Fax (44-1904) 45 57 33Information@psd.defra.gsi.gov.uk |
|
PUN-DK |
Punya Innovations |
Almevej 180DK-3250 GillelejeTlf (45) 48 30 17 27Fax (45) 48 30 22 27punya@worldonline.dk |
|
PYC-FR |
Pyco SA |
Route de Saint-Sever — Haut-MaucoBP 27F-40001 Mont-de-Marsan CedexTéléphone (33) 558 05 89 37Télécopieur (33) 558 05 89 36alain.dini@bayercropscience.com |
|
RAG-DE |
agrostulln GmbH |
Werksweg 2D-92551 StullnTel.: (49) 9435 39 32 27Fax: (49) 9435 39 32 28m.meier@agrostulln.de |
|
RHZ-NL |
Rhizopon B.V. |
PO Box 110NL-2394 ZG HazerswoudeTel.: (31-71) 341 51 46Fax: (31-71) 341 58 29info@rhizopon.com |
|
RLE-ES |
Repsolypf Lubricantes y Especialidades |
Orense, 34E-28020 MadridTel. (34) 913 48 78 00Fax (34) 913 23 70 32msalinasg@repsolypf.com |
|
RML-IT |
R.A.M.OIL S.p.A. |
Via Filichito 16/ATavernanova di CasalnuovoI-80013 NapoliTel. (39) 081 519 51 11Fax (39) 081 842 10 79info@ramoil.it |
|
RUS-GB |
Russell Fine Chemicals Ltd |
68 Third AvenueDeeside Industrial ParkDeeside CH5 2LAUnited KingdomTel. (44-1244) 28 13 33Fax (44-1244) 28 18 78alzaidi@Russellipm.com |
|
SAA-PT |
Sapec Agro, S.A. |
Rua Victor Cordon, 19PT-1200-482 LisboaTel.: (351-21) 322 27 49Fax: (351-21) 322 27 35cesmeraldo@agro.sapec.pt |
|
SAG-FR |
JP Industrie |
16 avenue des ChateaupiedsF-92565 Rueil-MalmaisonTéléphone (33) 155 47 96 60Télécopieur (33) 155 47 96 69service.client@jp-industrie.com |
|
SAM-FR |
Samabiol SA |
La Grande MarineF-84800 Isle-sur-la-SorgueTéléphone (33) 490 21 44 44Télécopieur (33) 490 38 10 55samabiol@samabiol.com |
|
SAP-FR |
Saphyr |
ZI des TerriersF-06600 AntibesTéléphone (33) 493 74 73 13Télécopieur (33) 493 74 82 30saphyr@rotenone.com |
|
SBS-IT |
Serbios S.r.l. |
VIA E.FERMI, 112I-45021 Badia Polesine (RO)Tel. (39) 0425 59 06 22Fax (39) 0425 59 08 76info@serbios.it |
|
SDQ-ES |
Sociedad Española de Desarrollos Químicos, SA (SEDQ) |
Avenida Diagonal, 352, entresueloE-08013 BarcelonaTel. (34) 934 58 40 00Fax (34) 934 58 40 07jcastella@sedq.es |
|
SEI-NL |
Shin-Etsu International Europe B V |
World Trade Center AmsterdamStrawinskylaan B-827NL-1077 XX AmsterdamTel.: (31-20) 662 13 59Fax: (31-20) 664 90 00shinint@attglobal.net |
|
SFS-FR |
Scotts France SAS |
21 chemin de la SauvegardeBP 92F-69136 Écully CedexTéléphone (33) 472 86 67 00Télécopieur (33) 472 86 67 86nicolas.le-brun-keris@scottsco.com |
|
SHC-FR |
SiberHegner & Cie. (France) S.A. |
1475 quai du Rhône — BP 266F-01702 Miribel CedexTéléphone (33) 478 55 78 73Télécopieur (33) 478 55 78 87thomas.steinmann@SiberHegner.com |
|
SIC-IT |
SICIT 2000 S.p.A. |
Via Arzignano 80I-36072 Chiampo (VI)Tel. (39) 0444 62 31 32Fax (39) 0444 62 59 03sicitspa@tin.it |
|
SIP-IT |
Sipcam SpA |
Via Sempione 195I-20016 Pero (Milano)Tel. (39) 02 35 37 84 00Fax (39) 02 339 02 75sipcam@sipcam.it |
|
SLY-FR |
Solvay SA |
12 cours Albert 1erF-75383 Paris cedex 08Téléphone (33) 140 75 80 00Télécopieur (33) 142 89 12 57frederik.degraeve@Solvay.com |
|
SML-GB |
M/s Sulphur Mills Limited |
C/o Unity Garments LtdUnity House, Fletcher StreetBolton BL36 N3United KingdomTel. (44-1204) 49 73 78Fax (44-1204) 49 73 78sml@sulphurmills.com |
|
SOL-GB |
Solvay Interox Ltd |
PO Box 7Warrington WA4 6HBUnited KingdomTel. (44-1925) 64 35 12Fax (44-1925) 65 58 56tom.candy@solvay.com |
|
SOX-GB |
Sorex Limited |
St Michael's Industrial EstateWidnes WA8 8TJUnited KingdomTel. (44-151) 420-7151Fax (44-151) 495-1163rogers@sorex.com |
|
SPL-GB |
Sphere Laboratories (London) Ltd |
The YewsMain StreetChilton OX11 0RZUnited KingdomTel. (44-1235) 83 18 02Fax (44-1235) 83 38 96bobn@jrfint.demon.co.uk |
|
SPU-DE |
Spiess-Urania Chemicals GmbH |
Heidenkampsweg 77D-20097 HamburgTel.: (49) 4023 65 20Fax: (49) 4023 65 22 80mail@spiess-urania.com |
|
STG-GB |
Stephenson Group Limited |
PO Box 305Listerhills RoadBradford BD7 1HYUnited KingdomTel. (44-1274) 72 38 11Fax (44-1274) 37 01 08ssc@stephensongroup.co.uk |
|
STI-IT |
S.T.I. — Solfotecnica Italiana S.p.A. |
Via Evangelista Torricelli, 2I-48010 Cotignola (RA)Tel. (39) 0545 99 24 55Fax (39) 0545 90 82 87aamenta@solfotecnica.com |
|
SUM-FR |
Valent BioSciences |
Parc d'affaires de Crécy2 rue Claude-ChappeF-69370 Saint-Didier-au-Mont-d'OrTéléphone (33) 478 64 32 60Télécopieur (33) 478 47 70 05denise.munday@valentbiosciences.ch |
|
SUN-BE |
Sun Oil Company Belgium NV |
Ingberthoeveweg 4B-2630 AartselaarTel.: (32-3) 458 12 30Fax: (31-3) 458 14 78info@sunoco.be |
|
SYN-GB |
Syngenta |
European Regional CentreSurrey Research Park, Priestley RoadGuildford GU2 7YHUnited KingdomTel. (44-1483) 26 02 40Fax (44-1483) 26 00 19simon.baker@syngenta.com |
|
TAE-DE |
Earth BioScience, Inc. (formerly Taensa, Inc.) |
c/o Bayer AGAgricultural Centre MonheimD-51368 Leverkusendhd@dhd-consulting.de |
|
TBE-ES |
Tratamientos Bio-Ecológicos, SA |
Polígono Industrial Los Urreas, 31E-30730 San Javier (Murcia)Tel. (34) 968 57 20 04Fax (34) 968 19 22 51trabe1@telefonica.net |
|
TEM-DE |
Temmen GmbH |
Ankerstraße 74D-65795 HattersheimTel.: (49) 6145 99 19-0Fax: (49) 6145 99 19-19temmen@aol.com |
|
TOM-FR |
Arysta Paris SAS |
18 avenue de l'OpéraF-75001 ParisTéléphone (33) 142 96 14 56Télécopieur (33) 142 97 52 91oudar@par.tomen.co.uk |
|
TOT-FR |
Total Solvants |
51 esplanade du Général-de-GaulleLa Défense 10F-92069 Paris-La DéfenseTéléphone (33) 141 35 59 83Télécopieur (33) 141 35 51 34christian.varescon@totalfinaelf.com |
|
TRD-FR |
La Toulousaine de Recherche et de Développement |
Zone industrielle de PompignalF-31190 MiremontTéléphone (33) 561 50 61 58Télécopieur (33) 561 50 84 42anne.paulhe@latoulousaine.fr |
|
TRF-DE |
Trifolio-M GmbH |
Sonnenstraße 22D-35633 LahnauTel.: (49) 6441 631 14Fax: (49) 6441 646 50info@trifolio-m.de |
|
UPL-GB |
United Phosphorus Ltd |
Chadwick HouseBirchwood ParkWarrington XWA3 6AEUnited KingdomTel. (44-1925) 85 90 09Fax (44-1925) 85 19 51julie@uplukreg.demon.co.uk |
|
VAL-IT |
Valagro S.p.A. |
Zona IndustrialeI-66040 Piazzano di Atessa — ChietiTel. (39) 0872 88 11Fax (39) 0872 88 13 95o.larocca@valagro.com |
|
VIO-GR |
Vioryl S.A. |
36 Viltaniotis St.Kato KifissiaGR-145 64 AthensΤηλ.: (30) 210-807 46 03Φαξ: (30) 210-807 46 81vioryl@vioryl.gr |
|
VIT-GB |
Vitax Ltd |
Owen StreetCoalville LE67 3DEUnited KingdomTel. (44-530) 51 00 60Fax (44-530) 51 02 99tech@vitax.co.uk |
|
VRA-FI |
Verdera Oy |
P.O. Box 330Porkkalankatu 3FI-00101 HelsinkiTel. (358) 10 86 15 11Fax (358) 108 62 11 26maiju.heith@kemira.com |
|
XED-FR |
Xeda International SA |
2 ZA de la CrauF-13670 Saint-AndiolTéléphone (33) 490 90 23 23Télécopieur (33) 490 90 23 20xeda.int@wanadoo.fr |
|
XOM-FR |
ExxonMobil |
2 rue des MartinetsF-92500 Rueil-MalmaisonTéléphone (33) 147 10 60 00Télécopieur (33) 147 10 66 03olivier.traversaz@exxonmobil.com |
|
ZOL-IT |
Zolfital SpA |
Via di S. Teresa 23I-00198 Roma RMTel. (39) 06 854 10 96Fax (39) 06 854 31 49zolfital@tin.it |
ANNEX III
Co-ordinating authority in the Member States (more details are available at the following webside: http://www.europa.eu.int/comm/food/fs/ph_ps/pro/index_en.htm)
AUSTRIA
Bundesamt für Ernährungssicherheit
Landwirtschaftliche Untersuchungen und Forschung Wien
Spargelfeldstraße 191
A-1220 Wien
BELGIUM
Service public fédéral Santé publique, Sécurité de la Chaîne alimentaire et Alimentation
Direction-générale Animaux, Végétaux et Alimentation
Centre administratif de l'État, bâtiment Arcades
B-1010 Bruxelles
CYPRUS
Ministry of Agriculture,
Natural resources and Environment
Department of Agriculture
Loukis Akritas Ave.
1412 Lefkosia
CZECH REPUBLIC
State Phytosanitary Administration,
PPP Division
Zemědělská 1A
61300 Brno
DENMARK
Ministry of Environment and Energy
Danish Environmental Protection Agency
Pesticide Division
Strandgade 29
DK-1401 Copenhagen K
ESTONIA
Estonian Plant Production Inspectorate
Plant Protection Department
Teaduse 2
75501 Saku
Harju Country
Estonia
FINLAND
Plant Production Inspection Centre
Pesticide Division
P.O. BOX 42
FI-00501 Helsinki
FRANCE
Ministère de l’agriculture, de l’alimentation, de la pêche et des affaires rurales
Sous direction de la qualité et de la protection des végétaux
Bureau de la réglementation et de la mise sur le marché des intrans
251, rue de Vaugirard
F-75732 Paris Cedex 15
GERMANY
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL)
Abteilung 2, Pflanzenschutzmittel
Dienststelle Braunschweig
Messeweg 11—12
D-38104 Braunschweig
GREECE
Hellenic Republic
Ministry of Agriculture
General Directorate of Plant Produce
Directorate of Plant Produce Protection
Department of Pesticides
3-4 Hippokratous Street
GR-10164 Athens
HUNGARY
Central Service for Plant Protection and Soil conservation
Budaörsi út 141–145.
1118 Budapest
IRELAND
Pesticide Control Service
Department of Agriculture and Food
Abbotstown Laboratory Complex
Abbotstown, Castleknock
IRL-Dublin 15
ITALY
Ministero della Salute
Direzione Generale della Sanità Pubblica Veterinaria, degli Alimenti e della Nutrizione
Piazza G. Marconi, 25
I-00144 Roma
LATVIA
State Plant Protection Service
Plant Protection Department
Republikas laukums 2,
Riga, LV-1981
Latvia
LITHUANIA
State Plant Protection Service
Kalvarijų 62
09304 Vilnius
Lithuania
LUXEMBOURG
Administration des Services Techniques de l’Agriculture
Service de la protection des Végétaux
Boîte postale 1904
16, route d’Esch
L-1019 Luxembourg
MALTA
Ministry for rural Affairs & The Environment
Plant Health Department
Plant Biotechnology Centre
Annibale Preca Street
NETHERLANDS
College voor de Toelating van Bestrijdingsmiddelen
PO Box 217
NL-6700 AE Wageningen
POLAND
Ministerstwo Rolnictwa i Rozwoju Wsi
Departament Hodowli i Ochrony Roślin
ul. Wspólna 30
00-930 Warszawa
PORTUGAL
Direcção-Geral de Protecção das Culturas,
Quinta do Marquês
P-2780 Oeiras
SLOVAK REPUBLIC
Ministry of Agriculture of the Slovak Republic,
Plant Commodities Department
Dobrovičova 12
81266 Bratislava
SLOVENIA
Ministry of Agriculture, Forestry and Food,
Phytosanitary Administration Republic of Slovenia
6 Einspielerjeva,
SI-1000 Ljubljana
SPAIN
Ministerio de Agricultura, Pesca y Alimentación
Dirección General de Agricultura
Subdirección General de Medios de Producción Agrícolas
Avda. Alfonso XII, 62
E-28014 Madrid
SWEDEN
The Swedish Chemicals Inspectorate, KemI
P.O. Box 2
SE-172 13 Sundbyberg
UNITED KINGDOM
Pesticides Safety Directorate
Department for Environment, Food and Rural Affairs
Mallard House,
Kings Pool,
3 Peasholme Green,
York, YO1 7PX
ANNEX IV
Organisations in the Member States to be contacted concerning further details on the payment of the fees referred to in Article 30 and to which such fees have to be paid
AUSTRIA
Bundesamt für Ernährungssicherheit
Landwirtschaftliche Untersuchungen und Forschung Wien
Spargelfeldstraße 191
A-1220 Wien
BELGIUM
Fonds budgétaire des matières premières et des produits
Service public fédéral Santé publique, Sécurité de la Chaîne alimentaire et Alimentation
Direction-générale Animaux, Végétaux et Alimentation
Centre administratif de l'État, bâtiment Arcades
B-1010 Bruxelles
CYPRUS
Ministry of Agriculture,
Natural resources and Environment
Department of Agriculture
Loukis Akritas Ave.
1412 Lefkosia
CZECH REPUBLIC
State Phytosanitary Administration,
PPP Division
Zemědělská 1A
61300 Brno
DENMARK
Ministry of Environment and Energy
Danish Environmental Protection Agency
Strandgade 29
DK-1401 Copenhagen K
ESTONIA
Estonian Plant Production Inspectorate
Plant Protection Department
Teaduse 2
75501 Saku
Harju Country
Estonia
FINLAND
Plant Production Inspection Centre
Pesticide Division
PO BOX 42
FI-00501 Helsinki
Bank and account:
Nordea Bank
Account: 166030-101330
IBAN: FI3716603000101330
SWIFT: NDEAFIHH
FI-00501 Helsinki
FRANCE
Ministère de l’Agriculture et de la Pêche
Bureau de la Réglementation des Produits antiparasitaires — 251 rue de Vaugirard
F-75732 Paris Cedex 15
GERMANY
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL)
Abteilung 2, Pflanzenschutzmittel
Dienststelle Braunschweig
Messeweg 11—12
D-38104 Braunschweig
GREECE
Hellenic Republic
Ministry of Agriculture
General Directorate of Plant Produce
Directorate of Plant Produce Protection
Department of Pesticides
3-4 Hippokratous Street
GR-10164 Athens
HUNGARY
Central Service for Plant Protection and Soil conservation
Budaörsi út 141–145.
1118 Budapest
IRELAND
Pesticide Control Service
Department of Agriculture, Food and Rural Development
Abbotstown Laboratory Complex
Abbotstown, Castleknock
IRL-Dublin 15
ITALY
Tesoreria Provinciale dello Stato di Viterbo
N. di conto corrente postale n. 52744570
IBAN: IT 43
CIN: E
BIC: BPPIITRRXXX
ABI: 7601
CAB: 14500
LATVIA
State Plant Protection Service
Plant Protection Department
Republikas laukums 2,
Riga, LV-1981
Latvia
LITHUANIA
State Plant Protection Service
Kalvarijų 62
09304 Vilnius
Lithuania
LUXEMBOURG
Administration des Services Techniques de l’Agriculture
Boîte postale 1904
L-1019 Luxembourg
MALTA
Ministry for rural Affairs & The Environment
Plant Health Department
Plant Biotechnology Centre
Annibale Preca Street
THE NETHERLANDS
College voor de Toelating van Bestrijdingsmiddelen
PO Box 217
NL-6700 AE Wageningen
POLAND
Ministerstwo Rolnictwa i Rozwoju Wsi
Departament Hodowli i Ochrony Roślin
ul. Wspólna 30
00-930 Warszawa
PORTUGAL
Direcção-Geral de Protecção das Culturas,
Quinta do Marquês,
P-2780 OEIRAS
Número de conta: 003505840003800793097
Banco: Caixa Geral de Depósitos
SLOVAK REPUBLIC
Ministry of Agriculture of the Slovak Republic,
Plant Commodities Department
Dobrovičova 12
81266 Bratislava
SLOVENIA
Ministry of Agriculture, Forestry and Food,
Phytosanitary Administration Republic of Slovenia
6 Einspielerjeva,
SI-1000 Ljubljana
SPAIN
Ministerio de Agricultura, Pesca y Alimentación
Dirección General de Agricultura
Subdirección General de Medios de Producción Agrícolas
Avda. Alfonso XII, 62
E-28014 Madrid
SWEDEN
The Swedish Chemicals Inspectorate, KemI
P.O. Box 2
SE-172 13 Sundbyberg
National Giro Account: 4465054 – 7
UNITED KINGDOM
Pesticides Safety Directorate
Department for Environment, Food and Rural Affairs
Mallard House,
Kings Pool,
3 Peasholme Green,
York, YO1 7PX
ANNEX V
Details to be notified by producers in new Member States
The notification must be made on paper and by e-mail.
The notification shall contain the following information:
1. IDENTIFICATION DATA ON THE NOTIFIER
1.1. Manufacturer of the active substance as defined in point (b) of Article 2 of Regulation (EC) No 1112/2002 (name, address, including location of plant):
1.2. Name and address of the producer as defined in point (a) of Article 2 of Regulation (EC) No 1112/2002 including the name of the (natural) person responsible for the notification and further engagements resulting from this Regulation.
(a) Telephone No
(b) Telefax No
(c) E-Mail Address
(a) Contact:
(b) Alternative:
2. INFORMATION TO FACILITATE IDENTIFICATION
2.1. Common name (proposed or ISO-accepted where appropriate) specifying, where relevant, any variants thereof such as salts, esters or amines produced by the manufacturer. For micro-organisms the species, and where relevant, subspecies name
2.2. Chemical name (IUPAC and CAS nomenclature) (where appropriate).
2.3. CAS, CIPAC and EEC numbers (if available).
2.4. Empirical and structural formula, molecular mass (where appropriate).
2.5. Any other information considered necessary to facilitate identification, for example method of manufacture/extraction or origin of materials from which the substance is manufactured.
2.6. Specification of purity of the active substance in g/kg or g/l (as appropriate).
3. FURTHER INFORMATION
3.1. For each Member State a list of crops/uses for which plant protection products containing the active substance are currently authorised or used.
4. UNDERTAKING
The notifier undertakes to submit to the designated coordinating authority of the designated rapporteur Member State the dossiers within the time limits provided for in Article 12 of Regulation (EC) No 2229/2004.
The notifier declares that he is aware that he will be charged a fee by Member States at the time of the submission of the full dossier.
The notifier confirms that the above information is honest and correct.
The notifier declares that an authorisation by the manufacturer to act as his sole representative for the purpose of complying with this Regulation is enclosed if necessary.
Signature (of the person competent to act for the manufacturer mentioned under 1.1.)
ANNEX VI
Criteria for clear indications of no harmful effects
An active substance shall be considered as fulfilling the requirement, as referred to in Article 24b, 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 ( 11 ); (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 ( 12 ). |
|
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 VII
Criteria for clear indications of harmful effects
An active substance shall be considered as fulfilling the requirement, as referred to in Article 24f, of there being clear indications that on the basis on the available data, and which have been evaluated in accordance with the provisions of Article 24d, 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. |
( 1 ) OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2004/71/EC (OJ L 309, 6.10.2004, p. 6).
( 2 ) OJ L 366, 15.12.1992, p. 10. Regulation as last amended by Regulation (EC) No 2266/2000 (OJ L 259, 13.10.2000, p. 27).
( 3 ) OJ L 55, 29.2.2000, p. 25. Regulation as last amended by Regulation (EC) No 1044/2003 (OJ L 151, 19.6.2003, p. 32).
( 4 ) OJ L 224, 21.8.2002, p. 23. Regulation as amended by Regulation (EC) No 1744/2004 (OJ L 311, 8.10.2004, p. 23).
( 5 ) OJ L 168, 27.6.2002, p. 14.
( 6 ) OJ L 33, 8.2.1979, p. 36. Directive as last amended by Regulation (EC) No 850/2004 (OJ L 158, 30.4.2004, p. 7).
( 7 ) OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Regulation (EC) No 1642/2003 (L 245, 29.9.2003, p. 4).
( 8 ) COM(2001) 444 final.
( 9 ) OJ L 123, 24.4.1998, p. 1. Directive as last amended by Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).
( 10 ) The active substances for which no notifier is identified in Column C are active substances as meant in Article 1(1)(b) of this Regulation.
( 11 ) OJ L 158, 30.4.2004, p. 7; corrected by OJ L 229, 29.6.2004, p. 5.
( 12 ) OJ L 396, 30.12.2006, p. 1; corrected by OJ L 136, 29.5.2007, p. 3.