Renewal of ai for which Annex I approval expires in 2013 and 2014

Date:05-20-2011

Council Regulation 1107/2009 fully comes into legal effect on 14 June 2011.  All active substances included on Annex I of Directive 91/414 after December 2012 will have to be renewed under procedures established under Regulation 1107/2009.

Notifiers and potential notifiers for active substances for which inclusion expires during 2013 and 2014 should now be informing the EU Commission of their intention to support these actives. 

The Commission is expected to publish a regulation detailing the procedures for all of the remaining Annex I inclusions in late 2011/early 2012, with the first dossier submissions of these active substances due in September 2013.  In the meantime the Commission need to gauge the number of dossiers they can expect to receive.

In addition to the need to update the dossiers to reflect changes in scientific and technical knowledge since the first inclusion, notifiers will also be required to report on an up to date review of published scientific peer-reviewed open literature.

JSC already has considerable experience in advising clients on the active substance renewal procedure for maintaining active substance approvals including preparing Updating Statements, carrying out data gap analysis, reviewing published literature and preparing dossiers.