CHAPTER 1
ADMISSIBILITY
SECTION 1
Application for renewal
Article 1
Submission of the application
Article 2
Format and contents of the application
Article 3
Checking of the application
Article 4
Contacts prior to submission of supplementary dossiers
Article 5
Access to the application
SECTION 2
Supplementary dossiers
Article 6
Submission of supplementary dossiers
Article 7
Contents of supplementary dossiers
Article 8
Admissibility of the application
Article 9
Replacement of the applicant
Article 10
Refusal of renewal where applications are inadmissible
CHAPTER 2
ASSESSMENT
Article 11
Assessment by the assessing competent authority
Article 11a
For the purposes of assessment of the approval criteria set...
Article 11b
The Agency shall endeavour to adopt the opinion on a...
Article 12
Comments on the draft renewal assessment report
Article 13
Conclusion by the assessing competent authority
Article 13a
Fees and charges
Article 14
Renewal decision
CHAPTER 3
TRANSITIONAL AND FINAL PROVISIONS
Article 15
Transitional provisions
Article 16
Entry into force and application
ANNEX
Format for applications, as provided for in Article 2(1)
The application shall be in writing, signed by the applicant,...
A copy of the application shall be sent to the...
MODEL
1.
Information concerning the applicant
1.1.
Name and address of the applicant including the name of...
2.
Information to facilitate identification
2.1.
Common name (proposed or ISO-accepted) specifying, where relevant, any variants...
2.2.
Chemical name (IUPAC and CAS nomenclature).
2.3.
CAS, CIPAC and EC numbers (if available).
2.4.
Empirical and structural formula, molecular mass.
2.5.
Specification of purity of the active substance in g/kg which...
2.6.
Classification and labelling of the active substance in accordance with...
3.
New information
3.1.
List of new information intended to be submitted together with...
3.2.
List of new studies intended to be submitted on vertebrate...
3.3.
Timetable of any new and ongoing studies.
Commission Implementing Regulation (EU) No 844/2012
of 18 September 2012
setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to 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 , and in particular Article 19 thereof,
Whereas:
(1)
Regulation (EC) No 1107/2009 provides that the approval of an active substance may be renewed upon expiry.
(2)
It is appropriate to set out the provisions necessary for the implementation of the renewal procedure.
(3)
In particular, periods should be set for the different steps of the renewal procedure to ensure that it functions properly.
(4)
Rules should be set out as regards confidentiality and the publication of the application for renewal, the supplementary dossiers and their updates.
(5)
Rules should also be set out as regards the submission of the application for renewal and its contents and format. The applicant should be obliged to justify the submission of new information and to list separately studies concerning vertebrate animals that they intend to submit.
(6)
Rules should be set out as regards the checking of the application by the rapporteur Member State.
(7)
In order to ensure the proper functioning of the renewal procedure, the rapporteur Member State should, at the applicant’s request, organise prior to the submission of the supplementary dossier, a meeting to discuss the application.
(8)
The supplementary dossiers submitted for renewal should, in particular, include necessary new data and new risk assessments and demonstrate why such data and risk assessments are necessary.
(9)
Rules should be set out as regards the establishment of the admissibility of the application by the rapporteur Member State.
(10)
Where all applications submitted are inadmissible, the Commission should adopt a Regulation on the non-renewal of the active substance concerned.
(11)
Rules should be set out to ensure an independent, objective and transparent assessment of the active substance.
(12)
The applicant, the Member States, with the exception of the rapporteur Member State, and the public should be given the opportunity to submit comments on the draft renewal assessment report.
(13)
The European Food Safety Authority should provide conclusions and organise consultations of experts, except where the Commission informs it that a conclusion is not necessary.
(14)
Rules should be set out as regards the renewal report and the adoption of a regulation on the renewal of the approval of the active substance.
(15)
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 should continue to apply with respect to the renewal of the approval of the active substances listed in Annex I thereto.
(16)
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:
OJ L 309, 24.11.2009, p. 1.
OJ L 322, 8.12.2010, p. 10.