New rules on the renewal of biocidal product authorisations subject to mutual recognition
The aim is to avoid duplicating work and improve the consistency of the renewal of authorisation processes in the EU.
Helsinki, 4 June 2014 - Today, a Commission delegated regulation enters into force providing supplementary rules for the renewal of authorisations that are subject to or granted through mutual recognition. They apply when a Member State has granted the first authorisation and a different Member State has granted an authorisation through mutual recognition of the first authorisation.
The new procedures affect the authorisation of biocidal products or biocidal product families with the same terms and conditions in all the relevant Member States. A single application for renewal should be made that covers all the linked national authorisations. In particular, the rules specify:
- the content of the application;
- the procedures for the submission of applications by companies and their validation and evaluation by competent authorities;
- the timelines for a competent authority's decision on renewal;
- the period of grace for existing stocks of the biocidal product to be made available on the market if no application for renewal is submitted.
As with all national authorisations, companies have to submit an application for renewal at least 550 days before the expiry date of the authorisation. Product authorisations can be granted for an initial maximum period of 10 years and the renewal should not be granted for a longer period than the initial authorisation.
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 regarding the rules for renewal of the authorisation of biocidal products subject to mutual recognition (text with EEA relevance)