Commission Delegated Regulation (EU) No 492/2014 of 7 March 2014 supplementing Regulation (EU) No 528/2012 of the European Parliament and of the Council as regards the rules for the renewal of authorisations of biocidal products subject to mutual recognition  Text with EEA relevance

14.5.2014 EN Official Journal of the European Union L 139/1
COMMISSION DELEGATED REGULATION (EU) No 492/2014
of 7 March 2014
supplementing Regulation (EU) No 528/2012 of the European Parliament and of the Council as regards the rules for the renewal of authorisations of biocidal products subject to mutual recognition
(Text with EEA relevance)
THE EUROPEAN COMMISSION
,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular the first paragraph of Article 40 thereof,
Whereas:
(1) It is appropriate to lay down supplementary rules for the renewal of national authorisations having been subject to mutual recognition in accordance with Article 4 of Directive 98/8/EC of the European Parliament and of the Council (2) or with Articles 33 and 34 of Regulation (EU) No 528/2012, both in the Member States where the first authorisations were granted and in those Member States having granted authorisations through mutual recognition of the first authorisations.
(2) In order to avoid unnecessary duplication of work and to ensure consistency, renewal of authorisations having been subject to mutual recognition should in the first place be managed by the competent authority of one single reference Member State. In order to provide flexibility to applicants and competent authorities, the applicant should have the opportunity to choose the reference Member State subject to the latter's agreement.
(3) In order to facilitate the smooth running of the procedure and the tasks to be carried out by the competent authorities, the scope of this Regulation should be limited to those authorisations having, apart from limited exceptions, the same terms and conditions in all the Member States at the time of the application for renewal. For other national authorisations, an application for renewal should be submitted to the Member State in question in accordance with Article 31 of Regulation (EU) No 528/2012.
(4) The content of an application for renewal of a national authorisation is specified under Article 31 of Regulation (EU) No 528/2012. However, for applications for renewal of national authorisations granted on the basis of mutual recognition, the content of the application should be further specified, in particular to facilitate the work of the Member States involved in the renewal of these authorisations.
(5) To take into account the workload associated with the evaluation, the time allowed for processing an application should depend on whether or not a full evaluation needs to be performed.
(6) In order to provide the same level of protection when an authorisation is renewed as when it is first granted, the maximum validity of the renewed authorisations should not exceed that of the initial authorisations. In addition, phasing-out provisions for the existing products on the market of Member States should be set for those authorisations for which an application for renewal is not submitted or is rejected.
(7) It is appropriate to refer any disagreement in the evaluation of renewal applications to the coordination group established under Regulation (EU) No 528/2012 for the purpose of examining disagreements relating to product authorisation, and to allow derogations from mutual recognition based on the general grounds for such derogations laid down in Article 37 of that Regulation.
(8) In order to bring further predictability, guidelines on the details related to the handling of renewals should be developed by the Agency and regularly updated on the basis of experience and scientific or technical progress,