This Regulation lays down detailed rules for the submission and appraisal of applications for inclusion in Annex I to Directive 91/414/EEC of active substances which were not on the market on 26 July 1993.
Commission Regulation (EU) No 188/2011 of 25 February 2011 laying down detailed rules for the implementation of Council Directive 91/414/EEC as regards the procedure for the assessment of active substances which were not on the market 2 years after the date of notification of that Directive Text with EEA relevance
Commission Regulation (EU) No 188/2011 of 25 February 2011 laying down detailed rules for the implementation of Council Directive 91/414/EEC as regards the procedure for the assessment of active substances which were not on the market 2 years after the date of notification of that Directive 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(1), and in particular Article 6(5) thereof,
Whereas:
It is necessary to adopt rules on a procedure for the submission and appraisal of applications for inclusion in Annex I to Directive 91/414/EEC of active substances which were not yet on the market 2 years after the date of notification of that Directive. In particular periods should be set for the different steps of that procedure to ensure that they are carried out rapidly.
Additional information submitted after the application and the dossiers should only be taken into account if it was requested by the European Food Safety Authority, hereinafter ‘the Authority’, or the rapporteur Member State and submitted within the time period set.
As regards applications submitted before the entry into force of this Regulation transitional measures should be provided for. In particular, it is appropriate to extend the period which may be granted to the applicant to submit additional information requested by the Authority or the rapporteur Member State. As regards such applications, it is further necessary to set periods for the circulation of the draft assessment report by the Authority and the submission of comments by the Member States, other than the rapporteur Member State, and the applicant.
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:
Article 1 Scope
Article 2 Application
1.
An applicant wishing to secure the inclusion in Annex I to Directive 91/414/EEC of an active substance covered by Article 1 shall submit an application for that active substance to a Member State, hereinafter referred to as ‘rapporteur Member State’, together with a summary dossier and a complete dossier, as provided for in Article 3, or a scientifically reasoned justification for not providing certain parts of those dossiers, demonstrating that the active substance fulfils the criteria provided for in Article 5 of that Directive.
For the purposes of this Regulation ‘applicant’ means the person who manufactures the active substance himself 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.
2.
When submitting his application, the applicant may, pursuant to Article 14 of Directive 91/414/EEC, request certain parts of the dossiers referred to in paragraph 1 of this Article to be kept confidential. The applicant shall explain for each document or each part of a document why it is to be considered as confidential.
Member States shall assess the confidentiality requests. Upon a request for access to information, the rapporteur Member State shall decide what information is to be kept confidential.
The applicant shall submit separately the information to be kept confidential.
The applicant shall at the same time submit any claims for data protection pursuant to Article 13 of Directive 91/414/EEC.
Article 3 Dossiers
1.
The summary dossier shall include the following:
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data with respect to one or more representative uses of at least one plant protection product containing the active substance, demonstrating that the requirements of Article 5 of Directive 91/414/EEC are fulfilled;
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for each point of the data requirements for the active substance referred to in Annex II to Directive 91/414/EEC, the summaries and results of tests and studies, the name of their owner and of the person or institute that carried out the tests and studies;
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for each point of the data requirements for the plant protection product referred to in Annex III to Directive 91/414/EEC, the summaries and results of tests and studies, the name of their owner and of the person or institute that carried out the tests and studies relevant to the assessment of the criteria referred to in Article 5 of that Directive taking into account that data gaps in a dossier, as set out in Annex II or Annex III to that Directive, resulting from the proposed range of representative uses, may lead to restrictions in the inclusion in Annex I to that Directive;
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a checklist demonstrating that the dossier provided for in paragraph 2 is complete;
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the reasons why the test and study reports submitted are necessary for inclusion of the active substance concerned;
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an assessment of all information submitted;
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where relevant, a copy of an application for a residue level as referred to in Article 7 of Regulation (EC) No 396/2005 of the European Parliament and of the Council(2) or a justification for not supplying such copy of an application.
2.
The complete dossier shall contain the full text of the individual test and study reports concerning all the information referred to in points (b) and (c) of paragraph 1 with a list of those tests and studies.
Article 4 Completeness check of the dossiers
1.
Within 3 months from receiving the application, the rapporteur Member State shall check whether the dossiers submitted with the application contain all the elements provided for in Article 3, using the checklist referred to in Article 3(1)(d). It shall also check the requests for confidentiality referred to in Article 2(2) and the list of tests and studies submitted pursuant to Article 3(2).
2.
Where one or more of the elements provided for in Article 3 are missing, the rapporteur Member State shall inform the applicant, setting a time period for their submission; such time period shall be no more than 3 months.
3.
Where at the end of the period, referred to in paragraph 2, the applicant has not submitted the missing elements, the rapporteur Member State shall inform the applicant, the Commission and the other Member States that the application is rejected.
4.
Where the dossiers submitted with the application contain all the elements provided for in Article 3, the rapporteur Member State shall notify the applicant, the Commission, the other Member States and the European Food Safety Authority, hereinafter ‘the Authority’, of the completeness of the application. After receiving that notification, the applicant shall immediately forward those dossiers to the other Member States, the Commission and the Authority, including the information about those parts of the dossiers in respect of which confidentiality has been requested as referred to in Article 2(2).
5.
Within 4 months from the date of receipt of the notification referred to in paragraph 4, a decision shall be adopted in accordance with Article 6(3) of Directive 91/414/EEC establishing that the dossiers submitted fulfil the requirements of Annexes II and III to that Directive, hereinafter ‘completeness decision’.