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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 91414eectext with EEA Relevance Regulation
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 2002/1112;
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 2002/1112.
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
The following definitions shall also apply:
For the purpose of this Regulation, the definitions set out in Article 2 of Directive 91/414/EEC and Article 2 of Regulation 2002/1112 shall apply.
a
‘notifier’ means the natural or legal person who has submitted a notification in accordance with:
i
Regulation 2002/1112, 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.
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.
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.
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.
Member States shall withdraw authorisations of plant protection products containing such active substances within the period prescribed in the Decision.
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.
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 2002/1112 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 PBPMD the notifier may submit:
a
a copy of the dossier submitted under PBPMD;
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 2002/1490, 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 2002/1490;
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
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.
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.
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
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.
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.
Article 12: Time limits for submission of dossiers
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 . 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.
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.
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.
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.
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.
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
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).
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 10ticles' class='internal-link article' href='#art_5' data-bs-toggle='popover' data-bs-trigger='hover focus' data-bs-content='Submission of dossiers by more than one notifier' data-bs-placement='top' >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 10ticles' class='internal-link article' href='#art_5' data-bs-toggle='popover' data-bs-trigger='hover focus' data-bs-content='Submission of dossiers by more than one notifier' data-bs-placement='top' >5, 6 and 10.
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 10ticles' class='internal-link article' href='#art_5' data-bs-toggle='popover' data-bs-trigger='hover focus' data-bs-content='Submission of dossiers by more than one notifier' data-bs-placement='top' >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 PBPMD 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.
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.
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.
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.
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
2
It may be decided to replace a rapporteur Member State for a particular active substance by another Member State where:
a
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.
The original Member State shall return to the notifier the part of the fee referred to in Article 30 which has not been used. The newly designated rapporteur Member State may require the payment of a further fee in accordance with Article 30.
Article 24: Evaluation by the EFSA
1
The EFSA shall, within 30 days of the date of receipt of the draft assessment report as provided for in Article 21(1) or Article 22(1) of this Regulation, check that it clearly complies with the format recommended in accordance with the procedure referred to in Article 19 of Directive 91/414/EEC.
In exceptional cases where the draft assessment report clearly does not fulfil those requirements the Commission shall agree with the EFSA and the rapporteur Member State on a period for resubmission of an amended report which shall not exceed three months.
In exceptional cases where the draft assessment report clearly does not fulfil those requirements the Commission shall agree with the EFSA and the rapporteur Member State on a period for resubmission of an amended report which shall not exceed three months.
2
The EFSA shall circulate the draft assessment report to the other Member States and to the Commission and may organise a consultation of experts including the rapporteur Member State.
3
The EFSA may consult some or all of the notifiers of active substances referred to in Annex I on the draft assessment report or parts thereof on the relevant active substances.
4
Without prejudice to Article 7 of Directive 91/414/EEC, submission of new studies shall not be accepted by the EFSA after receipt of the draft assessment report referred to in paragraph 1 of this Article.
However, the rapporteur Member State, with the agreement of the EFSA, may request the notifiers to submit within specified time limits further data considered by the rapporteur Member State or the EFSA necessary to clarify the dossier.
However, the rapporteur Member State, with the agreement of the EFSA, may request the notifiers to submit within specified time limits further data considered by the rapporteur Member State or the EFSA necessary to clarify the dossier.
5
The EFSA shall make available at specific request or keep available for consultation by any person the following:
a
the draft assessment report, except the elements thereof which have been accepted as confidential in accordance with Article 14 of Directive 91/414/EEC;
b
the list of any data required for the evaluation of the possible inclusion of the active substance in Annex I to Directive 91/414/EEC, as finalised by the EFSA.
6
The EFSA shall evaluate the draft assessment report and submit its evaluation to the Commission on whether the active substance may be expected to meet the requirements of Article 5(1) of Directive 91/414/EEC at the latest one year from the date on which it has received both the dossier from the notifier, under Article 15(3) of this Regulation, and also the draft assessment report checked for compliance in accordance with paragraph 1 of this Article.
Where appropriate, the EFSA shall give its evaluation of the available options claimed to meet the requirements of Article 5(1) of Directive 91/414/EEC and any data requirements identified.
The Commission and the EFSA shall agree on a schedule for the submission of the evaluation in order to facilitate the planning of the work. The Commission and the EFSA shall also agree on the format of the evaluation.
Where appropriate, the EFSA shall give its evaluation of the available options claimed to meet the requirements of Article 5(1) of Directive 91/414/EEC and any data requirements identified.
The Commission and the EFSA shall agree on a schedule for the submission of the evaluation in order to facilitate the planning of the work. The Commission and the EFSA shall also agree on the format of the evaluation.
Article 25: Presentation of a draft Directive or draft Decision
1
The Commission shall present a draft review report at the latest four months from the date of receipt of the EFSA evaluation provided for in Article 24(6)
2
Without prejudice to any proposal it may submit with a view to amending the Annex to Directive 79/117/EEC, and on the basis of the finalised review report provided for in Article 26 of this Regulation, the Commission shall present to the Standing Committee on the Food Chain and Animal Health:
a
a draft Directive to include the active substance in Annex I to Directive 91/414/EEC stating where appropriate the conditions for inclusion; such conditions may include the time limit for such inclusion; or
b
a draft Decision addressed to the Member States pursuant to the fourth subparagraph of Article 8(2) of Directive 91/414/EEC, not to include that active substance in Annex I to Directive 91/414/EEC, stating the reasons for the non-inclusion and requiring the Member States to withdraw the authorisations of plant protection products containing the active substance.
The Directive or Decision shall be adopted in accordance with the procedure referred to in Article 19 of Directive 91/414/EEC.
3
In addition to the conditions for inclusion proposed under paragraph 2(a), the Commission may indicate if it has identified any information missing from the dossier which may be required by Member States when they come to grant authorisations under Article 4 of Directive 91/414/EEC.
Article 26: Finalised review report
The conclusions of the Standing Committee on the Food Chain and Animal Health, excluding any parts which refer to confidential information contained in the dossiers and determined as such in accordance with Article 14 of Directive 91/414/EEC, shall be made publicly available.
Article 27: Suspension of time limits
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.
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.
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='articles' class='internal-link article' href='#art_19' data-bs-toggle='popover' data-bs-trigger='hover focus' data-bs-content='Specific conditions for evaluations of dossiers for substances listed in Parts B to G of Annex I' data-bs-placement='top' >19to 122'articles' class='internal-link article' href='#art_5' data-bs-toggle='popover' data-bs-trigger='hover focus' data-bs-content='Submission of dossiers by more than one notifier' data-bs-placement='top' >5 to 10 or in the draft assessment report concerning an active substance referred to in Articles 59 to10='articles' class='internal-link article' href='#art_19' data-bs-toggle='popover' data-bs-trigger='hover focus' data-bs-content='Specific conditions for evaluations of dossiers for substances listed in Parts B to G of Annex I' data-bs-placement='top' >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.
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.
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.
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.
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 . Official Journal of the European Union
Recital 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.
Recital 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.
Recital 3
Commission Regulation 2000/451 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.
Recital 4
Regulation 2000/451 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 2002/1490 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 2002/451 ( 4 ) also provides for the third stage of the programme of works. The third stage is also ongoing.
Recital 5
Commission Regulation 2002/1112 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.
Recital 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.
Recital 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.
Recital 8
Regulation 2002/178 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.
Recital 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.
Recital 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.
Recital 11
In order to avoid duplication of work, and in particular experiments involving vertebrate animals, producers should be encouraged to submit collective dossiers.
Recital 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.
Recital 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.
Recital 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.
Recital 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 PBPMD of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market ( 9 ) .
Recital 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.
Recital 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.
Recital 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.
Recital 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.
Recital 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.
Recital 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.
Recital 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.
Recital 23
The EFSA has been consulted on the proposed measures.
Recital 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,
List of active substances (column A), rapporteur Member States (column B) and notifying producers (code identification) (column C) ( *1 )
PART A
GROUP 1
LEAD RAPPORTEUR: IRELAND
Group 2.1.
LEAD RAPPORTEUR: FRANCE
LEAD RAPPORTEUR: UNITED KINGDOM
LEAD RAPPORTEUR: DENMARK
LEAD RAPPORTEUR: UNITED KINGDOM
LEAD RAPPORTEUR: SPAIN
Group 6.1.
LEAD RAPPORTEUR: BELGIUM
LEAD RAPPORTEUR: GREECE
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)
LEAD RAPPORTEURS: NETHERLANDS, SWEDEN
LEAD RAPPORTEUR: GERMANY
LEAD RAPPORTEUR: NETHERLANDS
LEAD RAPPORTEUR: POLAND
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
Amino acids/L-Glutamic acid
Germany AGR-ES
Amino acids/L-Tryptophan
Germany VAL-IT
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 acidCAS 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
Maltodextrin
Germany BCP-GB
Milk albumin
Czech Republic
Resins
Czech Republic
Sodium metabisulphite
Germany ESS-IT FRB-BE
Urea see also Group 6.2.
Greece FOC-GB OMX-GB
Wheat gluten
Finland ESA-NL
Propolis
Poland
GROUP 2
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.
Active substance
Rapporteur Member State Notifier
A
(B) (C)
Citronellol see also Group 6.1
United Kingdom ACP-FR
Citrus extract Notified as Bactericide
United Kingdom ALF-ES
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
Marigold extract
Spain ALF-ES
Mimosa Tenuiflora extract
Spain ALF-ES
Mustard powder
Latvia
Pepper Notified as repellant
United Kingdom BOO-GB PBI-GB
Plant oils/Black currant bud oil Notified as repellant
Sweden IAS-SE
Plant oils/Citronella oil
United Kingdom BAR-GB PBI-GB
Plant oils/Clove oil Notified as repellant
United Kingdom IAS-SE XED-FR
Plant oils/Etheric oil Eugenol Notified as repellant
Sweden DEN-NL DKI-NL
Plant oils/Eucalyptus oil
Sweden CFP-FR SIP-IT
Plant oils/Gaiac Wood oil
Spain IAS-SE
Plant oils/Garlic oil
United Kingdom DEN-NL GSO-GB
Plant oils/Lemongrass oil Notified as repellant
United Kingdom IAS-SE
Plant oils/Marjoram oil Notified as repellant
United Kingdom DEN-NL
Plant oils/Olive oil
United Kingdom DKI-NL
Plant oils/Orange oil Notified as repellant
United Kingdom GSO-GB
Plant oils/Pinus oil
Sweden ACP-FR DKI-NL IBT-IT MIB-NL SPU-DE
Plant oils/Rape seed oil
Spain CEL-DE CRU-IT DKI-NL FBL-DE NEU-DE NOV-FR PBI-GB VIT-GB
Plant oils/Soya oil Notified as repellant
Sweden DEN-NL DKI-NL PBC-ES
Plant oils/Spear mint oil
Sweden XED-FR
Plant oils/Sunflower oil
Spain DKI-NL PBI-GB TRD-FR
Plant oils/Thyme oil Notified as repellant
Sweden DEN-NL
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
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
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
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
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
Polyvinyl acetate
Slovak Republic
Repellants by smell of animal or plant origin/Blood meal
Belgium GYL-SE
Repellants by smell of animal or plant origin/Essential oils
Belgium BAR-GB
Trimethylamine hydrochloride
Belgium LLC-AT
Repellant by taste of vegetal and animal origin/extract of food grade/phosphoric acid and fish flour
Belgium
2-hydroxyethyl butyl sulfide
Poland
Asphalts
Poland
Group 6.2.
Active substance
Rapporteur Member State Notifier
A
(B) (C)
Ammonium bituminosulfonate
Hungary
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
Active substance
Rapporteur Member State Notifier
A
(B) (C)
2E,13Z-Octadecadien-1-yl acetate
SEI-NL SEI-NL SEI-NL
7E,9Z-Dodecadienyl acetate
BAS-DE CAL-FR ISA-IT LLC-AT RUS-GB SDQ-ES SEI-NL
7E,9Z-Dodecadienyl acetate; 7E,9E-Dodecadienyl acetate
SHC-FR
7Z,11E-Hexadecadien-1-yl acetate
SEI-NL SEI-NL
7Z,11Z-Hexadecadien-1-yl acetate; 7Z,11E-Hexadecadien-1-yl acetate
ABC-GB LLC-AT
9Z,12E-Tetradecadien-1-yl acetate
RUS-GB
E-11-Tetradecenyl acetate
SEI-NL
E-8-Dodecenyl acetate
CAL-FR SEI-NL
E,E-8,10-Dodecadien-1-ol
BAS-DE CAL-FR ISA-IT LLC-AT RUS-GB SDQ-ES SEI-NL SHC-FR VIO-GR MAS-BE
E/Z-8-Dodecenyl acetate; Z-8-Dodecenol
BAS-DE CAL-FR
E/Z-9-Dodecenyl acetate; E/Z-9-Dodecen-1-ol; Z-11-Tetradecen-1-yl acetate
ISA-IT LLC-AT SDQ-ES
E/Z-9-Dodecenyl acetate; E/Z-9-Dodecen-1-ol; Z-11-Tetradecen-1-yl acetate
TRF-DE
Z-11-Hexadecen-1-ol
SEI-NL
Z-11-Hexadecen-1-yl acetate
SEI-NL
Z-11-Hexadecenal
SEI-NL
Z-11-Hexadecenal; Z-11-Hexadecen-1-yl acetate
LLC-AT
Z-11-Tetradecen-1-yl acetate
BAS-DE SEI-NL
Z-13-Hexadecen-11-ynyl acetate
SDQ-ES
Z-13-Octadecenal
SEI-NL
Z-7-Tetradecenal
SEI-NL
Z-8-Dodecenol
SEI-NL
Z-8-Dodecenyl acetate
CAL-FR SDQ-ES SEI-NL
Z-8-Dodecenyl acetate; Dodecan-1-yl acetate
ISA-IT
Z-9-Dodecenyl acetate
BAS-DE LLC-AT SDQ-ES SEI-NL SHC-FR
Z-9-Dodecenyl acetate; Dodecan-1-yl acetate
ISA-IT
Z-9-Hexadecenal
SEI-NL
Z-9-Hexadecenal; Z-11-Hexadecenal; Z-13-Octadecenal
RUS-GB SDQ-ES
Z-9-Tetradecenyl acetate
SEI-NL
Z,E-3,7,11-trimethyl-2,6,10-dodecatrien-1-ol Farnesol
CAL-FR
Z,Z,Z,Z-7,13,16,19-Docosatetraen-1-yl isobutyrate
SHC-FR
1,4-Diaminobutane Putrescine
Austria LLC-AT
1,7-Dioxaspiro-5,5-undecan
VIO-GR
1-Tetradecanol
SEI-NL
2,6,6-Trimethylbicyclo[3.1.1]hept-2-enealpha-Pinen
SHC-FR
3,7,7-Trimethylbicyclo[4.1.0]hept-3-ene 3-Carene
3,7,11-Trimetil-1,6,10-dodecatrien-3-ol Nerolidol
CAL-FR
3,7 Dimethyl-26-octadien-1-ol Geraniol
CAL-FR
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-dioxaspiro4,4 nonanchalcogran
IR-1,3,3-Trimethyl-4,6-dioxatricyclo[3.3.1.0 2 , 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-olmyrcenol
E-2-Methyl-6-methylene-3,7-octadien-2-olisomyrcenol
2-Methyl-6-methylene-7-octen-4-ol Ipsenol
3-Methyl-3-buten-1-ol
Ethyl 2,4-decadienoate
Methyl p-hydroxybenzoate
p-Hydroxybenzoic acid
1-Methoxy-4-propenylbenzene Anethole
1-Methyl-4-isopropylidenecyclohex-1-ene Terpinolene
PART C
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
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
Active substance
Rapporteur Member State Notifier
A
(B) (C)
Didecyl-dimethylammonium chloride
Netherlands LON-DE
Formaldehyde Notified as Disinfectant
Netherlands PSD-GB
Glutaraldehyde
Belgium BAS-DE
HBTA High Boiling Tar Acid Notified as Disinfectant
Ireland JEY-GB
Hydrogen peroxide
Finland FBL-DE KIR-NL SPU-DE
Peracetic acid
Netherlands SOL-GB
Phoxim
Finland BCS-DE
Sodium hypochlorite
Netherlands SPU-DE
Sodium lauryl sulfate
Netherlands ADC-DE
Sodium p-toluenesulphon-chloramide
Netherlands PNP-NL
PART G
Active substance
Rapporteur Member State Notifier
A
(B) (C)
2-Methoxy-5-nitrofenol sodium salt
Poland
33-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
Di-1-p-menthene
Poland
Jasmonic acid
Hungary
N-phenylphthalamic acid
Hungary
Copper complex: 8-hydroxyquinolin with salicylic acid
Poland
1,3,5-Tir-2-hydroxyethyl-hexa-hydro-s-triazyne
Poland
( *1 ) 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.
List of notifiers' code identification, names and addresses
Code identification
Name Address
ABB-GB
Activa/Babolna Bromadiolone Task Force
hancock@chemregservs.co.uk
ABC-GB
AgriSense-BCS Ltd
mail@agrisense.demon.co.uk
ABP-DE
Agrinova GmbH
agrinova@t-online.de
ACI-BE
Agriculture Chimie Industrie International
roland.levy@swing.be
ACP-FR
Action Pin
actionpin@action-pin.fr
ADC-DE
ADC Agricultural Development Consulting
stratmannb@adc-eu.com
AGB-IT
Agribiotec srl
paolo.lameri@agribiotec.com
AGC-FR
Agrimer
fnicolas@agrimer.com
AGE-IT
Agrivet S.a.s. di Martinelli Maurizio & C.
r.martinelli@bo.nettuno.it
AGF-IT
Agrifutur srl
rkm@numerica.it
AGI-IT
Agrimix s.r.l.
info@agrimix.com
AGL-GB
Agil Ltd
murray@agil.com
AGN-IT
Zolfindustria Srl
agrindustria.srl@tin.it
AGR-ES
Agrichem, SA
info@agrichembio.com
AIF-IT
Aifar Agricola SRL
posta@aifar.it
ALF-ES
Alfarin Química SA
alfarin@asertel.es
ALT-FR
Alltech France
gbertin@alltech.com
AMI-IT
Aminco Srl
aminco@isiline.it
AMU-DE
Amu-Systeme
amu-hellenthal@t-online.de
AMV-GB
Amvac Chemical UK LTD
amvacat@easynet.co.uk
APT-GB
Activa/PelGar Brodifacoum and Difenacoum task Force
hancock@chemregservs.co.uk
ARC-NL
Arcadis PlanRealisatie B.V.
r.valk@arcadis.nl
ASF-IT
Asfaleia SRL.
postmaster@asfaleia.it
ASP-NL
Asepta B.V.
a.vandenende@asepta.nl
ASU-DE
Stähler Agrochemie GmbH & Co. KG
staehler-agro@staehler.com
AVA-AT
Avenarius-Agro GmbH
d.stroh@avenarius-agro.at
BAR-GB
Barrier Biotech Limited
nigelb@barrier-biotech.com
BAS-DE
BASF Aktiengesellschaft
siegfried.kersten@basf-ag.de
BBI-SE
Binab Bio-Innovation AB
info@binab.se
BCH-DE
Bayer/Dow Task Force via Bayer AG, Bayer Chemicals
klaus.stroech.ks@bayerchemicals.com
BAL-IE
BioAtlantis Ltd
jtostralee@eircom.net
BCP-GB
Biological Crop Protection Ltd
richardc@biological-crop-protection.co.uk
BCS-DE
Bayer CropScience AG
norbert.hesse@bayercropscience.com
BCS-FR
Bayer CropScience SA
martyn.griffiths@bayercropscience.com
BIB-ES
Bioibérica, SA
ibartoli@bioiberica.com
BNG-IE
Brown & Gillmer LTD.
bgfeeds@indigo.ie
BOB-DK
Borregaard BioPlant ApS
borregaard@bioplant.dk
BOO-GB
Bootman Chemical Safety Ltd.
info@bootmanchem.com
BPO-GB
BP Global Special Products Ltd
gspinfo@bp.com
BRA-GB
BRA-Europe
braeurope@aol.com
BRI-GB
Brimac Carbon Services
info@brimacservices.com
BRM-GB
BRM Agencies
brianmartin@cheshirehouse.co.uk
CAL-FR
Calliope SAS
fleconte@calliope-sa.com
CAP-FR
Capiscol
anne.coutelle@capiscol.com
CAT-PT
Cafum
cafum@cafum.pt
CEL-DE
Scotts Celaflor GmbH
otto.schweinsberg@scotts.com
CEQ-ES
Cequisa
xavier@cequisa.com
CER-FR
Cerexagri SA
mark.egsmose@cerexagri.com
CFP-FR
Nufarm SA
claude.chelle@fr.nufarm.com
CFW-DE
Chemische Fabrik Wülfel GmbH & Co. KG
cfw@wuelfel.de
CGL-GB
Catalytic Generators UK Limited
london@merricks.co.uk
CHE-DK
Cheminova A/S
info@cheminova.dk
CHM-FR
Chemimpex SA/Mauer
amselian@aol.com
CLM-NL
CLM research and advice Plc
clm@clm.nl
CNA-ES
Carus Nalon SL
carus@carusnalon.com
COL-FR
Coleacp
coleacp@coleacp.org
CPS-ES
Cepsa
aranzazu.guzman@madrid.cepsa.es
CRO-GB
Crompton Europe Limited
phil.pritchard@cromptoncorp.com
CRT-GB
Certis
certis@certiseurope.co.uk
CRU-IT
Cerrus sas
cerrus@tiscalinet.it
PZD-NL
Plantenziektenkundige Dienst
p.jellema@pd.agro.nl
CVX-BE
ChevronTexaco Technology Ghent
arickjl@chevrontexaco.com
DEN-NL
DeruNed bv
deruned@deruned.nl
DET-DE
Detia Freyberg GmbH
zulassung@detia-degesch.de
DKI-NL
Denka International B.V.
info@denka.nl
DUS-DE
Degussa Texturant Systems Deutschland GmbH & Co. KG
reception.hamburg@degussa.com
DXN-DK
Duxon ApS
duxon@mail.tele.dk
ECP-DE
Elefant Chemische Produkte GmbH
elefant-gmbh@web.de
ECY-GB
ECOspray Ltd
enquiries@ecospray.com
ERO-IT
Euroagro s.r.l.
euroagro_italia@libero.it
ESA-NL
ECOstyle BV
info@ecostyle.nl
ESS-IT
Esseco SpA
chemsupport@esseco.it
FBL-DE
FiBL Berlin e.V.
klaus-peter.wilbois@fibl.de
FER-GB
Feralco (UK) Limited
barry.lilley@feralco.com
FIN-GB
Fine Agrochemicals Ltd
enquire@fine-agrochemicals.com
FLU-DE
Flügel GmbH
info@fluegel-gmbh.de
FOC-GB
Forestry Commission
james.dewar@forestry.gsi.gov.uk
FRB-BE
Mr. John Ivey
JIvey94819@aol.com
FRU-DE
Frunol Delizia GmbH
info@frunol-delicia.de
GER-FR
Germicopa SAS
jeanyves.abgrall@germicopa.fr
GLO-BE
Globachem NV
globachem@globachem.com
GOB-IT
L. Gobbi s.r.l.
info@lgobbi.it
GOM-ES
Gomensoro Química SA
gomenki@arrakis.es
GSO-GB
Growing Success Organics Limited
info@growingsucess.org.uk
GTL-GB
Growth Technology Ltd
info@growthtechnology.com
GYL-SE
Gyllebo Gödning AB
gyllebo.plantskydd@telia.com
HAS-GR
House of Agriculture Spirou Aebe
agrospir@spirou.gr
HLA-GB
Headland Agrochemicals Ltd
stephen.foote@headlandgroup.com
HOC-GB
Hockley International Limited
mail@hockley.co.uk
HRM-BE
Hermoo Belgium NV
hermoo@hermoo.be
HTO-GB
Tioxide Europe Ltd
greg_s_mcnulty@huntsman.com
IAB-ES
IAB, SL (Investigaciones y Aplicaciones Biotecnológicas, SL)
iab@iabiotec.com
IAS-SE
Interagro Skog AB
walde@interagroskog.se
IBT-IT
Intrachem Bio Italia Spa
info@intrachem.it
IDB-ES
Idebio SL
idebio@helcom.es
IOI-DE
Imperial-Oel-Import Handelsgesellschaft mbH
info@imperial-oel-import.de
ISA-IT
Isagro S.p.A.
agiambelli@isagro.it
JAH-GB
J A Humphrey Agriculture
rhumphrey@nicobrand.com
JCA-ES
Julio Cabrero y Cía, SL
julio.cabrero@juliocabrero.com
JEY-GB
Jeyes Ltd
nigel.cooper@jeyes.co.uk
JSC-GB
JSC International Ltd
terry.tooby@jsci.co.uk
KBS-NL
Koppert Beheer BV
info@koppert.nl
KIR-NL
Kemira Chemicals B.V.
dees_van.kruyssen@kemira.com
KRO-DE
Kronos International, INC.
kronos.leverkusen@nli-usa.com
KWZ-AT
F. Joh. Kwizda GmbH
office@sarea.at
LGO-FR
Laboratoires GOËMAR SA
labo@goemar.com
LIP-FR
LiphaTech SA
ahoussin@merck.fr
LLC-AT
Consep GmbH
wmaxwald@lander.es
LON-DE
Lonza GmbH
gisbert.mehring@lonzagroup.com
LUX-NL
Luxan B.V.
luxan@luxan.nl
MAK-BE
Makhteshim-Agan International Coordination Centre (MAICC)
steve.kozlen@maicc.be
MAS-BE
Mitsui AgriScience International SA/BV
thorez@certiseurope.fr
MEL-NL
Melchemie Holland B.V.
info@melchemie.com
MEU-GB
Mycotech Europe LTD.
fjr@agrilexuk.com
MFS-GB
Macfarlan Smith Limited
melanie.jackson@macsmith.com
MGK-GB
MGK Europe Limited
glazer.barry@dorseylaw.com
MIB-NL
Micro Biomentor BV
info@microbiomentor.nl
NDC-SE
NIM Distribution Center AB
info@bionim.com
NEU-DE
W. Neudorff GmbH KG
wilhelmy@neudorff.de
NLI-AT
Nufarm GmbH & Co KG
eric.gibert@at.nufarm.com
NOV-FR
Novance SA
p.ravier@novance.com
NSA-GB
National Sulphuric Acid Association Limited
tomfleet@nsaa.org.uk or pamlatham@nsaa.org.uk
NSC-GB
Novigen Sciences Ltd
charris@novigensci.co.uk
OGT-IE
Oilean Glas Teoranta
smgo11@gofree.indigo.ie
OLE-BE
Oleon nv
info@oleon.com
OMX-GB
Omex Agriculture Ltd
enquire@omex.com
ORI-GB
Organic Insecticides
Fax 44-1494 81 65 78
OSK-ES
Osku España, SL
oskuesp@oskuesp.e.telefonica.net
PAB-SE
Perstorp Specialty Chemicals AB
perstorp@perstorp.com
PBC-ES
Procesos Bioquímicos Claramunt-Forner, SL
ana.perez@acgbioconsulting.com
PBI-GB
pbi Home & Garden Ltd
teresa.jones@pbi.co.uk
PBK-AT
Manfred Pfersich, Kenya Pyrethrum Information Centre
manfred.pfersich@kenya-pyrethrum.com
PEL-GB
PelGar International Ltd.
info@pelgar.demon.co.uk
PET-PT
Petrogal, S.A.
luis.brito.soares@galpenergia.com
PGM-GB
Pet and Garden Manufacturing plc
hancock@chemregservs.co.uk
PHS-FR
Physalys
ybassat@physalys.com
PHY-GR
Phytophyl N·G· Stavrakis
nista@otenet.gr
PKA-DE
Probis GmbH & Andermatt Biocontrol Taskforce
probis.knoch@t-online.de
PLS-IT
Polisenio srl.
polisenio@lamiarete.com
PNP-NL
PNP Holding bv
info@axcentive.com
PPP-FR
Plant Protection Projects
stephen.shires@wanadoo.fr
PRO-ES
Probelte, SA
probelte@probelte.es
PSD-GB
Pesticides Safety Directorate
Information@psd.defra.gsi.gov.uk
PUN-DK
Punya Innovations
punya@worldonline.dk
PYC-FR
Pyco SA
alain.dini@bayercropscience.com
RAG-DE
agrostulln GmbH
m.meier@agrostulln.de
RHZ-NL
Rhizopon B.V.
info@rhizopon.com
RLE-ES
Repsolypf Lubricantes y Especialidades
msalinasg@repsolypf.com
RML-IT
R.A.M.OIL S.p.A.
info@ramoil.it
RUS-GB
Russell Fine Chemicals Ltd
alzaidi@Russellipm.com
SAA-PT
Sapec Agro, S.A.
cesmeraldo@agro.sapec.pt
SAG-FR
JP Industrie
service.client@jp-industrie.com
SAM-FR
Samabiol SA
samabiol@samabiol.com
SAP-FR
Saphyr
saphyr@rotenone.com
SBS-IT
Serbios S.r.l.
info@serbios.it
SDQ-ES
Sociedad Española de Desarrollos Químicos, SA (SEDQ)
jcastella@sedq.es
SEI-NL
Shin-Etsu International Europe B V
shinint@attglobal.net
SFS-FR
Scotts France SAS
nicolas.le-brun-keris@scottsco.com
SHC-FR
SiberHegner & Cie. (France) S.A.
thomas.steinmann@SiberHegner.com
SIC-IT
SICIT 2000 S.p.A.
sicitspa@tin.it
SIP-IT
Sipcam SpA
sipcam@sipcam.it
SLY-FR
Solvay SA
frederik.degraeve@Solvay.com
SML-GB
M/s Sulphur Mills Limited
sml@sulphurmills.com
SOL-GB
Solvay Interox Ltd
tom.candy@solvay.com
SOX-GB
Sorex Limited
rogers@sorex.com
SPL-GB
Sphere Laboratories (London) Ltd
bobn@jrfint.demon.co.uk
SPU-DE
Spiess-Urania Chemicals GmbH
mail@spiess-urania.com
STG-GB
Stephenson Group Limited
ssc@stephensongroup.co.uk
STI-IT
S.T.I. — Solfotecnica Italiana S.p.A.
aamenta@solfotecnica.com
SUM-FR
Valent BioSciences
denise.munday@valentbiosciences.ch
SUN-BE
Sun Oil Company Belgium NV
info@sunoco.be
SYN-GB
Syngenta
simon.baker@syngenta.com
TAE-DE
Earth BioScience, Inc. (formerly Taensa, Inc.)
dhd@dhd-consulting.de
TBE-ES
Tratamientos Bio-Ecológicos, SA
trabe1@telefonica.net
TEM-DE
Temmen GmbH
temmen@aol.com
TOM-FR
Arysta Paris SAS
oudar@par.tomen.co.uk
TOT-FR
Total Solvants
christian.varescon@totalfinaelf.com
TRD-FR
La Toulousaine de Recherche et de Développement
anne.paulhe@latoulousaine.fr
TRF-DE
Trifolio-M GmbH
info@trifolio-m.de
UPL-GB
United Phosphorus Ltd
julie@uplukreg.demon.co.uk
VAL-IT
Valagro S.p.A.
o.larocca@valagro.com
VIO-GR
Vioryl S.A.
vioryl@vioryl.gr
VIT-GB
Vitax Ltd
tech@vitax.co.uk
VRA-FI
Verdera Oy
maiju.heith@kemira.com
XED-FR
Xeda International SA
xeda.int@wanadoo.fr
XOM-FR
ExxonMobil
olivier.traversaz@exxonmobil.com
ZOL-IT
Zolfital SpA
zolfital@tin.it
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
BELGIUM
CYPRUS
CZECH REPUBLIC
DENMARK
ESTONIA
FINLAND
FRANCE
GERMANY
GREECE
HUNGARY
IRELAND
ITALY
LATVIA
LITHUANIA
LUXEMBOURG
MALTA
NETHERLANDS
POLAND
PORTUGAL
SLOVAK REPUBLIC
SLOVENIA
SPAIN
SWEDEN
UNITED KINGDOM
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
BELGIUM
CYPRUS
CZECH REPUBLIC
DENMARK
ESTONIA
FINLAND
FRANCE
GERMANY
GREECE
HUNGARY
IRELAND
ITALY
LATVIA
LITHUANIA
LUXEMBOURG
MALTA
THE NETHERLANDS
POLAND
PORTUGAL
SLOVAK REPUBLIC
SLOVENIA
SPAIN
SWEDEN
UNITED KINGDOM
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 2002/1112 (name, address, including location of plant):
1.2.
Name and address of the producer as defined in point (a) of Article 2 of Regulation 2002/1112 including the name of the (natural) person responsible for the notification and further engagements resulting from this Regulation.
1.2.1.
a
Telephone No
b
Telefax No
c
E-Mail Address
1.2.2.
a
Contact:
b
Alternative:
2.
INFORMATION TO FACILITATE IDENTIFICATION
2.1.
Common name (proposed or ISO-accepted where appropriate) specifying, where relevant, any variants thereof such as salts, esters or amines produced by the manufacturer. For micro-organisms the species, and where relevant, subspecies name
2.2.
Chemical name (IUPAC and CAS nomenclature) (where appropriate).
2.3.
CAS, CIPAC and EEC numbers (if available).
2.4.
Empirical and structural formula, molecular mass (where appropriate).
2.5.
Any other information considered necessary to facilitate identification, for example method of manufacture/extraction or origin of materials from which the substance is manufactured.
2.6.
Specification of purity of the active substance in g/kg or g/l (as appropriate).
3.
FURTHER INFORMATION
3.1.
For each Member State a list of crops/uses for which plant protection products containing the active substance are currently authorised or used.
4.
UNDERTAKING The notifier undertakes to submit to the designated coordinating authority of the designated rapporteur Member State the dossiers within the time limits provided for in Article 12 of Regulation 2004/2229. 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.)
Footnote p0: This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 3 December 2004.