
COMMISSION REGULATION (EU) No 1141/2010 of 7 December 2010 laying down the procedure for the renewal of the inclusion of a second group of active substances in Annex I to Council Directive 91/414/EEC and establishing the list of those substances (Text with EEA relevance) 

THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market, and in particular Article 6(5) thereof,
Whereas:

(1) Directive 91/414/EEC provides that, on request, the inclusion of an active substance may be renewed.

(2) The Commission has received letters from several producers requesting a renewal for active substances included in Annex I to Directive 91/414/EEC and for which the inclusion period is to expire in 2011 and 2012.

(3) It is necessary to provide for a procedure for the submission and appraisal of applications for the renewal of the inclusion in Annex I to Directive 91/414/EEC of those active substances.

(4) Periods should be set for the different steps of that procedure to ensure that they are carried out rapidly.

(5) Producers wishing to secure the renewal of active substances covered by this Regulation should be required to apply to the relevant rapporteur Member State.

(6) Where two or more applications for the same active substance have been submitted separately and fulfil the requirements, the rapporteur Member States should communicate the updated contact details of each applicant to the other applicants to facilitate the submission of joint dossiers and to avoid, whenever possible, duplication of studies involving vertebrate animals.

(7) In order to ensure the efficiency of renewal procedures, rapporteur Member States should organise, prior to the submission of the dossiers, a meeting to discuss the state of the art of the active substance and consider whether and, if necessary, how the dossiers submitted for the first inclusion are to be updated.

(8) The dossiers submitted for renewal should include new data relevant to the active substance and new risk assessments to reflect any changes in data requirements and any changes in scientific or technical knowledge since the active substance was first included in Annex I to Directive 91/414/EEC, as reflected in guidance documents published by the Commission and in relevant opinions from the Scientific Committee on Plants or the European Food Safety Authority (hereinafter ‘the Authority’). The range of uses submitted should reflect the representative uses. The applicant should demonstrate, on the basis of the data submitted, that for one or more preparations the requirements of Article 5 of Directive 91/414/EEC will be fulfilled.

(9) The applicants should list separately vertebrate studies to be submitted with the dossier and the rapporteur Member States should make such lists available on request to promote early discussions on the sharing of vertebrates data to avoid duplication of vertebrate studies.

(10) Technical or scientific information about an active substance, in particular with regard to potentially dangerous effects, submitted within the relevant period by third parties should be taken into consideration in the evaluations. The applicants should be given the opportunity to comment on such information.

(11) The renewal assessment reports prepared by the rapporteur Member States may, where necessary, be the subject of a consultation of experts organised by the Authority on request of the Commission before they are submitted to the Standing Committee on the Food Chain and Animal Health.

(12) The rules on data protection of Article 13 of Directive 91/414/EEC are intended to provide an incentive to applicants to assemble the detailed studies required under Annexes II and III to that Directive. However, data protection should not be extended artificially by the production of new studies which are not needed to decide on the renewal of an active substance. To this end, applicants should be required to identify explicitly which studies are new compared to the original dossier used for the first inclusion of the substance in Annex I to Directive 91/414/EC and to provide justification for their submission.

(13) In view of the particular situation, where parts of the renewal procedure still take place while Directive 91/414/EEC applies while the decisions on the renewals will be taken under Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC, applicants are encouraged, as regards the format of the updating statement and the format and content of the dossier, to pay particular attention to the specific guidance documents published by the Commission.

(14) 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:

Scope
Article 1 

(1.) This Regulation lays down the procedure for the determination of the existing renewal application by the relevant competent authority as assessing competent authority.
(2.) The  “existing renewal application” is the application for the renewal of the approval of the active substance famoxadone which—
(a) was made to the United Kingdom as rapporteur Member State in accordance with Article 4 as it had effect immediately before  IP completion day, and
(b) is taken as being made under this Regulation and Article 15(1) of Regulation (EC) No 1107/2009 on the date on which it was made.
(3.) Anything done under this Regulation as it had effect immediately before  IP completion day  in relation to the existing renewal application—
(a) by the United Kingdom as rapporteur Member State;
(b) by the European Food Safety Authority;
is taken to have been done by the relevant competent authority as the assessing competent authority.
(4.) In this Article—
(a) “rapporteur Member State” has the meaning given in Article 2(c) as it had effect immediately before  IP completion day;
(b) the  “relevant competent authority” is the Secretary of State.
Definitions
Article 2 
For the purposes of this Regulation the following definitions shall apply:

((a)) ‘producer’ means the person who manufactures the active substance on his own or who contracts out the manufacturing to another party or a person designated by the manufacturer as his sole representative for the purpose of compliance with this Regulation;
((b)) ‘applicant’ means the producer who made the existing renewal application;
((c)) ...
((d)) ...
((e)) ...
((f)) ...
((g)) ‘Regulation (EC) No 1107/2009’ means Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market;
((h)) ‘assessing competent authority’ has the meaning given by  Article 15(1A)  of Regulation (EC) No 1107/2009;
((i)) ‘existing renewal application’ has the meaning given by Article 1(2).
Determination of existing renewal application
Article 2a 

(1.) Where the assessing competent authority considers that additional data from the applicant is necessary to finalise the relevant conclusion, the assessing competent authority may set a period of up to one month for the applicant to supply that data.
(2.) The assessing competent authority must notify the other competent authorities—
(a) as to the data received in accordance with paragraph 1, or
(b) where no data is received during the period described in paragraph 1.
(3.) On request from a competent authority, the assessing competent authority must provide a copy of data received in accordance with paragraph 1.
(4.) The assessing competent authority must send the other competent authorities a finalised conclusion as soon as reasonably practicable after the conclusion is finalised.
(5.) Article 20 of Regulation (EC) No 1107/2009 applies to the determination of an existing renewal application, and for the purpose of that Article an existing renewal application is taken to relate to each constituent territory.
(6.) In paragraph 1,  “relevant conclusion” means the conclusion of the European Food Safety Authority in respect of the existing renewal application, delivered in accordance with the second subparagraph of Article 16(2) as it had effect immediately before  IP completion day.
(7.) In this Article,  “competent authority” and  “constituent territory” have the meanings given in Article 3A of Regulation (EC) No 1107/2009.
Coordinating authority of the Member State
Article 3 
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Submission of application
Article 4 
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Format and content of application
Article 5 
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Checking of application
Article 6 
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Pre-submission contacts
Article 7 
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Access to the application
Article 8 
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Submission of supplementary dossiers
Article 9 
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Contents of supplementary dossiers
Article 10 
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Checking of supplementary dossiers
Article 11 
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Withdrawal and replacement of the applicant
Article 12 
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Submission of information by third parties
Article 13 
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Assessment by the rapporteur Member State and the co-rapporteur Member State
Article 14 
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Comments upon the renewal assessment report and access to that report and to the supplementary summary dossiers
Article 15 
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Evaluation of the renewal assessment report
Article 16 
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Review report and presentation of draft acts
Article 17 
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Access to review report
Article 18 
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Fees and charges
Article 19 
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Other charges, levies or fees
Article 20 
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Entry into force
Article 21 
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ANNEX I

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ANNEX II
Format for application, as provided for in Article 5(1)
The application shall be in writing, signed by the applicant, and sent by registered mail to the rapporteur Member State listed in column B of Annex I and to the co-rapporteur Member State listed in column C of Annex I.
A copy of the application without the updating statement shall be sent to the European Commission, DG Health and Consumers, unit E3, 1049 Brussels, Belgium and to the Authority, European Food Safety Authority, Largo N. Palli 5/A, 43121 Parma, Italy.
The application shall be submitted in accordance with the following model.
MODEL 
 1. Information concerning the applicant 
 1.1. Name and address of the applicant including the name of the natural person responsible for the application and further engagements resulting from this Regulation: 

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 2. Information to facilitate identification 
 2.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2.2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2.3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2.4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2.5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2.6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
An updating statement, as provided for in Article 5(2), shall be attached as an Annex to the application.
The applicant confirms that the above information submitted on … (date) is correct.
Signature (of the person competent to act for the applicant referred to under 1.1)
